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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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TELEFLEX INCORPORATED ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Communication or Transmission Problem (2896); Inadequate User Interface (2958); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 09/03/2020
Event Type  malfunction  
Event Description
Nursing was drawing labs from the sidearm of a patient when the balloon pump on that patient started alarming. The pump displayed "x's" over the helium and battery icons, the screen was frozen, and the pump stopped pumping. The pump also alarmed for an electrocardiogram lead fault, but all leads were on. Nursing could not restart the pump, and therefore chose to swap it out with a new pump. Manufacturer response for intra-aortic balloon pump, optimus ac3 (per site reporter). A software engineering manager at teleflex reviewed pump log files from the incident. Below is their response: "the red 'x' on battery and helium tank indicates that the user-interface/screen did not receive real-time data from the pump-control computer ("cpu"). There are a lot of possibilities which could cause it, in both hardware and software. If we know that the hardware is good, we'll dig in the software for a potential problem somewhere. " a teleflex field engineer came onsite to inspect the pump. Below is their response: "i could not reproduce the original reported symptoms: pump alarmed, stopped pumping, screen froze, flashing x's on he and batt icons. I replaced the cpm board revision 2 with a new cpu board revision 5 as that appears to be the most likely culprit if the problem was caused by a hardware issue. I also replaced the power switch as it was very sensitive. A slight tapping on the switch would cause the pump to restart. I also replaced the battery as the run time was only 40 minutes. The pump has been running in clinical engineering for the last 2 hours. I believe that it will be returned to service shortly. ".
 
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Brand NameARROW
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key10703916
MDR Text Key212092729
Report Number10703916
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/07/2020
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer10/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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