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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
Model Number IPN000302
Device Problems Device Alarm System (1012); Nonstandard Device (1420)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2020
Event Type  malfunction  
Event Description
While in use on a patient, a balloon pump alarmed "high baseline." clinical staff attempted to troubleshoot the issue but did not notice any obvious kinks in the tubing.The balloon pump was exchanged, and staff did not experience any further issues or alarms with the new pump.This incident appears to be related to a recent fda recall (z-2408-2020).Manufacturer response for balloon pump, ac3 optimu intra-aortic balloon pump (per site reporter).Teleflex sent a field engineer to our facility to inspect the balloon pump (see attached service report for results).Teleflex could not duplicate the symptom.The motor driver on the pump showed charring and discoloration consistent with the recent recall.The driver on this balloon pump was replaced with teleflex's newly designed driver.Teleflex plans to inspect and replace all motor drivers in our balloon pump fleet.
 
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Brand Name
ARROW
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key10294828
MDR Text Key199485788
Report Number10294828
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 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberIPN000302
Device Catalogue NumberIAP-0400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/06/2020
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer07/20/2020
Type of Device Usage N
Patient Sequence Number1
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