BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 4771417 · Received May 13, 2015

    Report

    Report Number
    1219856-2015-00110
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 27, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE PUMP ASSEMBLY (P/N 77-3200-001, S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF PUMP ASSEMBLY WAS PERFORMED. THE PCS ASSEMBLY WAS INSTALLED IN THE WRONG ORIENTATION AND LEFT A BIG GAB LOCATED AT BELLOW PORT. THE CONDOR POWER SUPPLY (P/N: 77-0063-001 S/N: (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF CONDOR POWER SUPPLY WAS PERFORMED AND FOUND NO OBVIOUS DAMAGE OR DEFECTS. THE BATTERY (P/N: 4000-9022-001, L/N 18F14G0042) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF BATTERY WAS PERFORMED AND NO ABNORMALITIES WERE FOUND. THE PUMP ASSEMBLY IN QUESTION WAS INSTALLED INTO KNOWN GOOD AUTOCAT2W AFTER RE-ORIENTATED TO THE CORRECT POSITION AND PERFORMED FUNCTIONAL TESTING. THE KNOWN GOOD AUTOCAT2W WITH THE PUMP ASSEMBLY IN QUESTION INSTALLED FAILED FUNCTIONAL TESTING. THE PUMP ALARMED "HELIUM LOSS 2" AFTER PURGE CYCLE. FURTHER INVESTIGATION WAS PERFORMED BY VISUALLY INSPECTED THE INTERNAL HARDWARE OF THE PUMP ASSEMBLY. DRIED BLOOD WAS NOTED INSIDE THE FACE SEAL PORT OF THE PCS ASSEMBLY. SEE OTHER REMARKS SECTION. OTHER REMARKS: NO FURTHER TESTING CAN BE PERFORMED DUE TO CONTAMINATION. THE POWER SUPPLY WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND FUNCTIONAL TESTING WAS PERFORMED. THE PUMP WAS STARTUP AS NORMAL. A POWER SUPPLY VOLTAGE CHECK WAS PERFORMED AND ALL VOLTAGES WERE WITHIN SPEC. THE PUMP WAS THEN LEFT TO RUN FOR 24 HOURS WITHOUT ANY ALARMS OR ERRORS WERE OCCURRED. THE PUMP WAS RUN ON BATTERY (BATTERY LOAD TEST) UNTIL THE IABP SHUT DOWN (>90MINUTES WITHIN SPEC). A BATTERY LOAD TEST WAS PERFORMED AFTER LETTING THE PUMP CHARGE FOR OVER 8 HOURS AND THE UNIT RAN FOR OVER 90 MINUTES. THE POWER SUPPLY PASSED ALL FUNCTIONAL TESTING. AN INSPECTION OF POWER SUPPLY INTERNAL HARDWARE WAS PERFORMED AND NO ABNORMALITY WAS FOUND. THE BATTERY WAS THEN INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND A BATTERY LOAD TEST WAS PERFORMED. THE IABP WAS RUN ON BATTERY UNTIL THE IABP SHUT DOWN. THE BATTERY WAS LEFT TO CHARGE IN THE PUMP FOR OVER 8 HOUR; THE PUMP SHUT OFF AFTER 61 MINUTES RAN (WARNING ALARM: AVAILABLE BATTERY POWER LESS THAN 20 MINUTES ALARM AFTER 53 MINUTES RAN, AVAILABLE BATTERY POWER LESS THAN 10 MINUTES ALARM AFTER 55 MINUTES RAN, AVAILABLE BATTERY POWER LESS THAN 5 MINUTES ALARM AFTER 58 MINUTES AND SHUT OFF AFTER 61 MINUTES ALARM). THE BATTERY FAILED A BATTERY LOAD TEST. PER OPERATOR'S MANUAL "THE BATTERY SHOULD BE MAINTAINED AT FULL CHARGE WHENEVER POSSIBLE. ARROW INTERNATIONAL RECOMMENDS THAT THE AUTOCAT2 SERIES IABP BE KEPT PLUGGED INTO A PROPER AC RECEPTACLE WHENEVER POSSIBLE INCLUDING TIME WHEN THE UNIT IS IN STORAGE OR NOT IN USE. THE POWER INDICATOR WILL ILLUMINATE WHEN AC POWER IS PRESENT. THE BATTERIES SHOULD NOT BE STORED IN A DISCHARGED STATE." A REVIEW OF THE SERVICE HISTORY INDICATES THIS BATTERY WAS INSTALLED ON (B)(6) 2014. THE BATTERY WAS IN USE FOR SEVEN MONTHS PRIOR TO THE REPORTED EVENT. ACCORDING TO THE FIELD SERVICE REPORT, THE FIELD SERVICE REPRESENTATIVE FOUND THE SECONDARY BATTERY CABLE WAS NOT CONNECTED TO THE CIRCUIT BREAKER DURING THE REPAIR. 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. CONCLUSION: THE REPORTED COMPLAINT OF "HELIUM LOSS ALARMS" IS CONFIRMED. THE REPORTED PROBLEM WAS REPRODUCED DURING THE FUNCTIONAL TEST. THE PUMP ALARMED HELIUM LOSS 2 RIGHT AFTER PURGE CYCLE. DRIED BLOOD WAS FOUND INSIDE THE PCS ASSEMBLY. NO FURTHER TESTING CAN BE PERFORMED DUE TO CONTAMINATION. THE CAUSE OF ALARMS IS UNDETERMINED. THE UNRELATED COMPLAINT OF "BATTERY DOES NOT HOLD CHARGE" IS CONFIRMED. THE BATTERY FAILED THE BATTERY LOAD TEST. THE PUMP SHUT OFF AFTER 61 MINUTES WHEN RUNNING ON BATTERY POWER. BATTERY LIFE IS DEPENDENT ON USAGE AND MAINTENANCE OF THE BATTERY. HOWEVER, NO PROBLEM WAS FOUND ON POWER SUPPLY. THE POWER SUPPLY PASSED FUNCTIONAL TESTING. THE CAUSE OF THE PREMATURE BATTERY FAILURE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: SYMPTOMS: PUMP HAD SEVERAL HELIUM LOSS ALARMS WHILE ON PT. FINDINGS / ACTIONS TAKEN: FOUND SMALL LEAK IN PUMP ASSEMBLY - ALSO NOTICED THAT PUMP ONLY RAN FOR 10 MINUTES ON BATTERY POWER. FOUND THE 2ND BATTERY DISCONNECTED AT CIRCUIT BREAKER. REPLACED- POWER SUPPLY AND BATTERY THAT WOULD NOT HOLD CHARGE. FCN LEVEL: 11 13 14 16. SOFTWARE LEVEL: 2.24. AT THE TIME OF THE EVENT THE PUMP WAS SWITCHED OUT AND ANOTHER PUMP USED FOR THIS PT. THE PT RECEIVED IABP THERAPY SUCCESSFULLY. THERE WAS NO REPORTED PT DEATH, INJURY OR COMPLICATIONS. THERE WAS NO REPORTED INTERRUPTION OR DELAY IN IABP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312387 AUTOCAT2 WAVE IABP AUTOCAT 2 WAVE PUMP CONSOLE DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1