BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE GERMAN

    MDR report key: 5620100 · Received April 29, 2016

    Report

    Report Number
    1219856-2016-00096
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    April 13, 2016
    Report Date
    April 15, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).. THE PCS ASSEMBLY (P/N 96-3006-001, S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE KNOWN GOOD AUTOCAT2W WITH THE PCS ASSEMBLY IN QUESTION INSTALLED, FAILED THE FUNCTIONAL TEST. THE PCS ASSEMBLY FAILED HELIUM LEAK TEST (PATIENT SIDE), THE BALLOON BASELINE PRESSURE DROPPED 8 MMHG APPROXIMATELY 15 MINUTES AFTER THE PUMP WAS INITIATED PUMPING. THE PCS ASSEMBLY WAS THEN REMOVED FROM THE PUMP. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED ONTO THE LEAK TESTER AND FAILED LEAK TESTING. A SMALL LEAK WAS NOTED TO BE COMING FROM THE DRAIN PORT. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED. DRIED BLOOD WAS NOTED INSIDE THE DRAIN VALVE AND MANIFOLD BLOCK WHERE THE DRAIN VALVE WAS CONNECTED TO. 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. SEE OTHER REMARKS SECTION. OTHER REMARKS: CONCLUSION: THE REPORTED COMPLAINT OF "ALARM, UNABLE TO REFILL" IS NOT CONFIRMED. THE REPORTED PROBLEM COULD NOT BE REPLICATED DURING THE FUNCTIONAL TEST; HOWEVER, THE PCS ASSEMBLY FAILED HELIUM LEAK TEST (PATIENT SIDE), THE BALLOON BASELINE PRESSURE DROPPED 8 MMHG APPROXIMATELY 15 MINUTES AFTER THE PUMP INITIATED PUMPING. A SMALL LEAK WAS NOTED TO BE COMING FROM THE DRAIN PORT. DRIED BLOOD WAS NOTED INSIDE THE DRAIN VALVE, AND THAT MAY HAVE CAUSED THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE/PARTS WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE OPERATING ROOM. AFTER CONNECTING THE INTRA-AORTIC BALLOON / INTRA-AORTIC BALLOON PUMP TO THE PATIENT THE PUMP ALARMED "FILLING IS NOT POSSIBLE." THE HELIUM TANK WAS SUFFICIENTLY FILLED WITH HELIUM. AS A RESULT ANOTHER PUMP WAS USED FOR THIS EVENT. A THIRD PARTY SERVICE PROVIDER HAS ALREADY CHECKED THE PUMP AND NOTED A DEFECT ON THE VALVE BLOCK. THERE WAS NO REPORTED PATIENT DEATH, INJURY, OR COMPLICATIONS. THERE WAS A DELAY IN THE PROCEDURE HOWEVER NO HARM TO THE PATIENT WAS REPORTED. THE PATIENT OUTCOME IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE OPERATING ROOM. AFTER CONNECTING THE INTRA-AORTIC BALLOON / INTRA-AORTIC BALLOON PUMP TO THE PATIENT THE PUMP ALARMED "FILLING IS NOT POSSIBLE." THE HELIUM TANK WAS SUFFICIENTLY FILLED WITH HELIUM. AS A RESULT ANOTHER PUMP WAS USED FOR THIS EVENT. A THIRD PARTY SERVICE PROVIDER HAS ALREADY CHECKED THE PUMP AND NOTED A DEFECT ON THE VALVE BLOCK. THERE WAS NO REPORTED PATIENT DEATH, INJURY, OR COMPLICATIONS. THERE WAS A DELAY IN THE PROCEDURE HOWEVER NO HARM TO THE PATIENT WAS REPORTED. THE PATIENT OUTCOME IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274997 AUTOCAT2 WAVE GERMAN INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001020079

    Patients

    Seq Age Sex Outcome Treatment
    1