examples of reported infusion pump problems fda
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Examples of Reported Infusion Pump Problems FDA

2021-8-19  This occurs in the absence of an identifiable problem. The infusion pump interprets a single keystroke as multiple keystrokes (a problem called a “key bounce”). For example, the user programs an...

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Reporting Problems with Infusion Pumps FDA

2021-6-28  If you suspect a problem with an infusion pump, we encourage you to file a report with FDA. Click here for examples of problems with infusion pumps.. Healthcare Professionals and Consumers: We ...

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Infusion Pumps FDA

2021-8-5  An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. Infusion pumps are in widespread use in clinical ...

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MAUDE Adverse Event Report: QCORE ... -

Device Problems Disconnection (1171); Fluid Leak (1250): Patient Problem Blood Loss (2597): Event Date 07/21/2014: Event Type Injury : Event Description Nurse reported that she found blood in the pt's bed and upon investigation, found that the tubing for the sapphire pca pump came apart at

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MAUDE Adverse Event Report: SIGMA SPECTRUM

2021-7-31  The infusion was noted to be running at nearly free flow by 2 rns. The infusion was stopped and removed from service. Pump appeared to be programmed correctly as noted by 2 rns and later confirmed by internal logs created in pump. During evaluation in clinical engineering the tubing was noted to be kinked when the door of the pump was opened.

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Letter to Infusion Pump Manufacturers FDA

2021-7-14  The most frequently reported external infusion pump device problems are: software error messages, human factors (which include but are not limited to

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FDA Calls for Reducing Infusion Pump Risks

2021-8-18  Infusion pump failures have been observed across multiple manufacturers and pump types, the FDA said, and many of the problems reported may be related to

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MAUDE Adverse Event Report: B.BRAUN ... -

The most frequent reported event is for a failure code 2156, and when the pump's event log is available, this has usually occurred at a transition in the pump's operating state, e. G. , at infusion complete when the pump would switch to kvo rate, or to start the pump, or to enter a programming value, etc. Other fail codes occur, too.

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MAUDE Adverse Event Report: SMITHS MEDICAL MD

User facility reported that on (b)(6) 2013 the nurse programmed the pump for infusion of morphine. The infusion prescription was 2 mg/hr with no bolus doses. Nurse noted that upon review of the pump programming, the infusion had the bolus dose option enabled, so nurse re-programmed the infusion. Infusion was started with patient on (b)(6).

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MAUDE Adverse Event Report: ANIMAS ... -

The reporter noted the patient did not receive any treatment above and beyond the usual routine of diabetes care and management, they remained on pump therapy. It was reported the pump¿s bolus and basal delivery settings were recently changed by a healthcare provider. The patient at the time of the call was in a hospital for orthopaedic surgery.

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MAUDE Adverse Event Report: B.BRAUN ... -

The most frequent reported event is for a failure code 2156, and when the pump's event log is available, this has usually occurred at a transition in the pump's operating state, e. G. , at infusion complete when the pump would switch to kvo rate, or to start the pump, or to enter a programming value, etc. Other fail codes occur, too.

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MAUDE Adverse Event Report: COVIDIEN ... -

The customer reported a non-reportable product malfunction and returned the sample for evaluation. The sample arrived at the manufacturing site without the packaging or lot number. The sample was evaluated on july 15, 2020 by visual inspection and pumping tester. Upon evaluation a leakage occurred from the aff valve which is externally supplied.

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MAUDE Adverse Event Report ... - accessdata.fda.gov

A review of the service history record for sn (b)(4) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue. Event Description It was reported that the device had failed preventive maintenance. There was

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MAUDE Adverse Event Report: SMITHS MEDICAL MD

User facility reported that on (b)(6) 2013 the nurse programmed the pump for infusion of morphine. The infusion prescription was 2 mg/hr with no bolus doses. Nurse noted that upon review of the pump programming, the infusion had the bolus dose option enabled, so nurse re-programmed the infusion. Infusion was started with patient on (b)(6).

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Insulin pumps have most reported problems in FDA

2021-8-7  Insulin pumps are small, computerized devices that mimic a normal pancreas, and have two main components — the pump and the infusion set. In addition to maintaining the device, users also must monitor their diets and manually input information, such as the rate of insulin delivery.

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FDA Calls for Reducing Infusion Pump Risks

2021-8-18  Infusion pump failures have been observed across multiple manufacturers and pump types, the FDA said, and many of the problems reported may be related to

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Insulin pumps have most reported problems in FDA

2018-11-27  Insulin pumps have most reported problems in FDA database. This Nov. 14, 2018 photo taken in Jackson, Miss., shows the Medtronic Paradigm REAL-Time Revel insulin pump of Polly Varnado's daughter ...

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Insulin pumps have most reported problems in FDA

2018-11-28  The report should include a device problem code and describe what happened, which can help pinpoint problems with a particular device.But an AP analysis of the FDA data found that Medtronic did not include a device problem code on virtually any of its more than 150,000 reports of deaths or injuries related to insulin pumps

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Insulin pumps have most reported problems in FDA

2018-11-27  The FDA said it was aware of that problem in older insulin pumps and has encouraged manufacturers to develop devices with memories that won’t be erased when power is lost or have the capability ...

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Insulin Pumps Have Most Reported Problems in FDA

2018-11-28  Insulin Pumps Have Most Reported Problems in FDA Database. ... Insulin pumps are small, computerized devices that mimic a normal pancreas, and have two main components — the pump and the infusion set. In addition to maintaining the device, users also must monitor their diets and manually input information, such as the rate of insulin delivery ...

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Insulin Pumps Have Most Reported Problems in FDA

2021-7-30  Insulin Pumps Have Most Reported Problems in FDA Database By Holbrook Mohr And Mitch Weiss, Medical Press. This Nov. 14, 2018 photo taken in Jackson, Miss., shows the Medtronic Paradigm REAL-Time Revel insulin pump of Polly Varnado’s

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FDA investigates reports of insulin pump problems -

2010-3-4  For example, in 225 of the 310 deaths reported, the “device problem was unknown and limited details of the event were provided and the root cause of the device failure was not confirmed by the ...

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Local Anesthetic Infusion Pump Systems Adverse Events ...

Following are examples of cases reported to the FDA and a summary of 40 injuries that occurred using direct local anesthetic infusion pump systems. These reports may represent sentinel events, i.e. , an early warning that is representative of a problem that is widespread, or

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Insulin pumps have most reported problems in FDA

2018-11-27  Insulin pumps have most reported problems in FDA database. By Associated Press Nov 27, 2018, 12:28pm MST ... Insulin pumps are small, computerized devices that mimic a normal pancreas, and have two main components — the pump and the infusion set. In addition to maintaining the device, users also must monitor their diets and manually input ...

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MAUDE Adverse Event Report ... - accessdata.fda.gov

A review of the service history record for sn (b)(4) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue. Event Description It was reported that the device had failed preventive maintenance. There was

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Insulin Pumps Have Most Reported Problems in FDA

2018-11-27  The FDA said it was aware of that problem in older insulin pumps and has encouraged manufacturers to develop devices with memories that won’t be erased when power is

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The Joint Commission’s Sentinel Event Alert 63 Smart ...

2021-8-10  Some examples of infusion pump problems reported to the FDA are: Confusion of controls like key bounce causing extra digits to be entered; Ambiguous trouble codes making problem isolation a challenge; Infusion pump fails to generate an audible alarm for a critical problem, such as an occlusion 3 . At Ivenix, we think differently

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Alaris Infusion Pump Recalled Due to Unresponsive or

2021-7-14  Alaris Infusion Pump Recalled Due to Unresponsive or Stuck Keys. The FDA reported the recall of Care Fusion 303’s BD Alaris Pump Module 8100 due to unresponsive or stuck keys during operation on April 16th, 2021. This is a class I recall where

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FDA gives Class I label to BD Alaris infusion pump system ...

2020-3-6  Dive Brief: FDA reported Friday that certain infusion pump systems recalled by BD on Feb. 4 have to date resulted in 55 injuries and one death. In the U.S., 774,000 devices were recalled due to software and system errors. According to FDA, those errors can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion

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