BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 17070829 · Received June 6, 2023

    Report

    Report Number
    3010532612-2023-00299
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 11, 2023
    Report Date
    May 11, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF "SCREEN BLACKED OUT AND A NOXIOUS SMELL CAME FROM THE PUMP" IS CONFIRMED. THE CUSTOMER RETURNED FOR INVESTIGATION AN AC3 RECORDER ASSEMBLY IN AN ELECTROSTATIC PROTECTIVE BAG (INP-1 AND INP-2). VISUAL INSPECTION OF THE RECORDER ASSEMBLY WAS PERFORMED, AND RESIDUE/CORROSION WAS NOTED ON THE PCB (INP-4 THROUGH INP-6). NO OTHER ABNORMALITY WAS NOTED (INP-3, INP-7, INP-8, AND INP-9). VISUAL INSPECTION OF THE INTERNAL HARDWARE WAS PERFORMED, AND NO FURTHER ABNORMALITIES OR CORROSION WERE NOTED (INP-10 THROUGH INP-12). FUNCTIONAL TESTING WITH THE IABP WAS NOT PERFORMED DUE TO THE RETURNED STATE OF THE DEVICE. 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. HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE DAMAGED RECORDER PCB COMPONENTS. THE MOST PROBABLE ROOT CAUSE IS SALINE THAT CAME INTO CONTACT WITH THE TOP OF THE RECORDING ASSEMBLY PCB. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE PUMP SCREEN WENT BLACK, AND THE PUMP EMITTED A NOXIOUS SMELL DURING A CATHETER LAB PROCEDURE. HOWEVER, THE PUMP WAS REPLACED QUICKLY." THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE PUMP SCREEN WENT BLACK, AND THE PUMP EMITTED A NOXIOUS SMELL DURING A CATHETER LAB PROCEDURE. HOWEVER, THE PUMP WAS REPLACED QUICKLY." THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093371 AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED| NOT REPORTED