BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 19831157 · Received July 25, 2024

    Report

    Report Number
    3010532612-2024-00590
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 27, 2024
    Report Date
    June 27, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). RETURNED FOR INVESTIGATION WAS A PCS ASSEMBLY (P/N 96-3006-001, S/N (B)(6)). THE SAMPLE WAS RETURNED IN A BROWN CARDBOARD BOX WITH PROTECTIVE SHIPPING PACKAGING. VISUAL INSPECTION OF THE PUMP ASSEMBLY WAS PERFORMED, AND DRIED BLOOD WAS NOTED INSIDE THE BELLOW PORT (INP-3) AND THE OUTLET PORT (INP-4). DUE TO BLOOD CONTAMINATION, NO FURTHER FUNCTIONAL TESTING CAN BE PERFORMED. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED. DRIED BLOOD WAS NOTED INSIDE THE MANIFOLD (ANP-1), THE VENT VALVE V1 (ANP-2, ANP-3), THE FILL VALVE V2 (ANP-4 THROUGH ANP-7), AND THE DRAIN VALVE V4 (ANP-8 THROUGH ANP-10). NOTE: BLOOD CAN ONLY ENTER THE IABP FROM AN IAB THAT DEVELOPS A LEAK. THE IFU STATES: "INTRA-AORTIC BALLOON MEMBRANE PERFORATION MAY OCCUR DURING IABP THERAPY. THE OCCURRENCE AND SEVERITY OF THE IAB PERFORATION IS UNPREDICTABLE AND MAY BE DUE TO PATIENT PHYSIOLOGY, ACCIDENTAL CONTACT WITH A SHARP INSTRUMENT OR BY CONTACT WITH CALCIFIED PLAQUE RESULTING IN MEMBRANE SURFACE ABRASION AND EVENTUAL PERFORATION. LARGE PERFORATIONS ARE RARE. SMALL PERFORATIONS CAN RESULT IN ASYMPTOMATIC RELEASE OF GAS. PERFORATION CAN CAUSE BLOOD TO APPEAR IN THE BALLOON CATHETER AND DRIVELINE TUBING." A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT OF "HELIUM LOSS ALARMS" IS CONFIRMED. DURING THE INVESTIGATION, DRIED BLOOD WAS NOTED INSIDE THE PCS ASSEMBLY WHICH POTENTIALLY CREATED A BLOCKAGE INSIDE THE PNEUMATIC SYSTEM. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE DRIED BLOOD BUILDUP INSIDE THE PCS ASSEMBLY. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NORMAL PUMP OPERATION SEVERAL HOURS AFTER START- UP "MULTIPLE HELIUM LOSS ALARMS RELATED TO SUSPECTED INTERNAL PUMP LEAK". ADDITIONAL INFORMATION STATES "ADDITIONAL INFORMATION STATES THAT TO CONTINUE THERAPY THE PUMP WAS SWITCHED OUT AND NO OTHER ISSUES NOTED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NORMAL PUMP OPERATION SEVERAL HOURS AFTER START- UP "MULTIPLE HELIUM LOSS ALARMS RELATED TO SUSPECTED INTERNAL PUMP LEAK". ADDITIONAL INFORMATION STATES ". ADDITIONAL INFORMATION STATES THAT TO CONTINUE THERAPY THE PUMP WAS SWITCHED OUT AND NO OTHER ISSUES NOTED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240382 AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female N/A.| N/A.