BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 10420558 · Received August 18, 2020

    Report

    Report Number
    3010532612-2020-00222
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 24, 2020
    Report Date
    July 28, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    UDI-DI
    30801902084966
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO IABP PART OR RECORDER STRIP HAS BEEN RETURNED TO TELEFLEX CHELMSFORD FOR INVESTIGATION. THE REPORTED COMPLAINT OF IABP HIGH BASELINE ALARM IS NOT ABLE TO BE CONFIRMED. THE PUMP WAS SERVICED BY THE DISTRIBUTOR'S SERVICE TECHNICIAN, AND THE MOTOR DRIVER WAS REPLACED. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE HIGH BASELINE ALARM MEETS THE NOTIFICATION CRITERIA OF THE EVENT INVESTIGATION FORM (EIF) AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA). THE EIF TEAM WAS NOTIFIED OF THIS COMPLAINT FOR FOLLOW-UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HIGH BASELINE ALARM, AND IT WAS NOTED THAT THE IABP STOPPED TWICE. AS A RESULT, THE IABP WAS SWAPPED OUT FOR ANOTHER IABP. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HIGH BASELINE ALARM, AND IT WAS NOTED THAT THE IABP STOPPED TWICE. AS A RESULT, THE IABP WAS SWAPPED OUT FOR ANOTHER IABP. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886162 AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL INC. IPN001112 N/A 30801902084966

    Patients

    Seq Age Sex Outcome Treatment
    1