BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 18869944 · Received March 8, 2024

    Report

    Report Number
    3010532612-2024-00198
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 23, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902084966
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). MEDWATCH REPORT # : MW5152165. RETURNED FOR INVESTIGATION WERE THE AC3 CPM BOARD WITH 3.11.00 FIRMWARE (P/N: 33-1000-003, S/N:(B)(6), DISPLAY HEAD (P/N 33-0100-003, S/N (B)(6), INTERNAL DVI CABLE (P/N: 33-3700-004) , EXTERNAL DVI CABLE (P/N: 33-3737-007), AND DVI ADAPTER (P/N: 5100-9200-020). VISUAL INSPECTION OF THE RETURNED SAMPLES WAS PERFORMED. RUST, CONTAMINATION, AND DAMAGE WERE NOTED TO THE EXTERNAL DVI CABLE AND DVI ADAPTER. THE EXTERNAL DVI CABLE HAD DAMAGE TO THE OUTER METAL PORTION OF THE BODY-SIDE OF THE CABLE AND CONTAMINATION WHICH APPEARED CONSISTENT WITH DRIED SALINE. THE DVI ADAPTER HAD RUST AND CONTAMINATION WHICH APPEARED CONSISTENT WITH DRIED SALINE ON ONE SIDE OF THE ADAPTER. NO OTHER ABNORMALITY WAS NOTED. THE EXTERNAL DVI CABLE AND DVI ADAPTER WERE TESTED FOR CONTINUITY TO DETERMINE IF THE SUBSTANCE WHICH APPEARED CONSISTENT WITH DRIED SALINE HAD CAUSED ANY SHORTS, AND BOTH COMPONENTS PASSED THE CONTINUITY TEST. THE EXTERNAL DVI CABLE AND DVI ADAPTER WERE INSTALLED INTO A KNOWN GOOD AC3. THE PUMP WAS POWERED UP SUCCESSFULLY. ALL VOLTAGES WERE WITHIN SPECIFICATION. PUMPING WAS INITIATED AND RAN SUCCESSFULLY FOR OVER 1 HOUR. A HIGH PRIORITY ALARM WAS PURPOSEFULLY GENERATED BY KINKING THE HELIUM PRESSURE TUBING AND THE PUMP CORRECTLY DETECTED THE ALARM CRITERIA, STOPPED PUMPING, CORNER SWITCH LED ILLUMINATED , ALARM TONE GENERATED, AND THE ALARM STRIP PRINTED OUT. THE INSTALLED COMPONENTS WERE MANIPULATED TO SEE IF EITHER COMPONENT HAD A POOR CONNECTION DUE TO THE CONTAMINATION AND NO DISPLAY ABNORMALITY WAS NOTED. THE DISPLAY HEAD, CPM, AND INTERNAL DVI CABLE WERE THEN INSTALLED INTO THE KNOWN GOOD AC3 SO THAT ALL RETURNED COMPONENTS WERE INSTALLED FOR TESTING. THE PUMP WAS POWERED UP SUCCESSFULLY. ALL VOLTAGES WERE WITHIN SPECIFICATION. PUMPING WAS INITIATED SUCCESSFULLY. A HIGH PRIORITY ALARM WAS PURPOSEFULLY GENERATED BY KINKING THE HELIUM PRESSURE TUBING AND THE PUMP CORRECTLY DETECTED THE ALARM CRITERIA, STOPPED PUMPING , CORNER SWITCH LED ILLUMINATED, ALARM TONE GENERATED, AND THE ALARM STRIP PRINTED OUT. THE AC3 RAN SUCCESSFULLY FOR OVER 35 MINUTES WHEN THE DISPLAY TURNED BLACK WHILE CONTINUING TO PUMP. A GRAPHICS RESET WAS ATTEMPTED BUT UNSUCCESSFUL. THE SYSTEM DID NOT RESPOND TO HARD KEY PRESSES. A POWER CYCLE RESOLVED THE ISSUE. TO FURTHER ATTEMPT TO ISOLATE THE ISSUE TO A SPECIFIC COMPONENT, THE CPM BOARD WAS REMOVED AND REPLACED WITH A LAB INVENTORY CPM BOARD. THE IABP POWERED UP AND RAN SUCCESSFULLY FOR OVER AN HOUR. ALL RETURNED COMPONENTS WERE REMOVED AND THE RETURNED CPM BOARD WAS THEN INSTALLED BACK INTO THE LAB INVENTORY AC3. THE IABP POWERED UP AND RAN SUCCESSFULLY FOR OVER AN HOUR. THE CPM BOARD WAS REMOVED AND THE INTERNAL DVI CABLE WAS INSTALLED. THE IABP POWERED UP AND RAN SUCCESSFULLY FOR OVER AN HOUR. THE DISPLAY ISSUE WAS NOT ABLE TO BE REPLICATED A SECOND TIME TO ISOLATE THE SOURCE OF THE ISSUE. 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 REPORTED COMPLAINT OF "THE SCREEN WENT BLANK" IS CONFIRMED. DURING THE COMPLAINT INVESTIGATION, THE DISPLAY WENT BLANK; HOWEVER, THE ISSUE WAS NOT ABLE TO BE DUPLICATED A SECOND TIME TO ISOLATE THE ISSUE TO A SPECIFIC COMPONENT. DURING VISUAL INSPECTION, RUST AND CONTAMINATION WHICH APPEARED CONSISTENT WITH DRIED SALINE WERE NOTED ON THE EXTERNAL DVI CABLE AND DVI ADAPTER, WHICH COULD HAVE CAUSED A SHORT. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE RECEIVED PRODUCTS DID NOT MEET SPECIFICATIONS DURING THE COMPLAINT INVESTIGATION DUE TO THE DISPLAY ERROR. THE ROOT CAUSE OF THE DISPLAY ERROR IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED "THEY HAVE 2 PUMPS (B)(6) AND (B)(6) THAT HAVE EACH EXPERIENCED A GRAPHICS RESET. THE SCREEN WENT BLANK, THE PUMP CONTINUED TO PUMP AND THE SCREEN THEN CAME BACK ON." ADDITIONAL INFORMATION REPORTS THE PUMP HAD TO BE REPLACED. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN".

    Description of Event or Problem · 0

    IT WAS REPORTED "THEY HAVE 2 PUMPS (B)(6) AND (B)(6) THAT HAVE EACH EXPERIENCED A GRAPHICS RESET. THE SCREEN WENT BLANK, THE PUMP CONTINUED TO PUMP AND THE SCREEN THEN CAME BACK ON." ADDITIONAL INFORMATION REPORTS THE PUMP HAD TO BE REPLACED. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194530 ARROW AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC N/A 30801902084966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown