BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE FRENCH

    MDR report key: 5776642 · Received July 7, 2016

    Report

    Report Number
    1219856-2016-00151
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    June 10, 2016
    Report Date
    June 13, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE PCS ASSEMBLY (P/N 96-3006-001W, S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED AND NO ABNORMALITIES WERE NOTED. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED INTO KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE KNOWN GOOD AUTOCAT2W WITH THE PCS ASSEMBLY IN QUESTION INSTALLED FAILED THE FUNCTIONAL TEST. THE PUMP ALARMED "HELIUM LOSS (2)" APPROXIMATELY 15 MINUTES AFTER 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 DETECTED TO BE COMING FROM THE VENT PORT V1. THE VENT VALVE V1 WAS POWERED WITH 12 VDC USING EXTERNAL POWER SUPPLY AND CLICKING SOUND WAS NOTED. THE EXTERNAL POWER SUPPLY WAS THEN SWITCHED ON/OFF MULTIPLE TIMES WITH TRIGGER EACH TIME. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED AND NO ABNORMALITIES WERE NOTED. 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, HELIUM LOSS" IS CONFIRMED. THE REPORTED ALARM WAS REPLICATED DURING THE FUNCTIONAL TEST. THE PUMP ALARMED HELIUM LOSS (2) APPROXIMATELY 15 MINUTES AFTER INITIATED PUMPING. A SMALL LEAK WAS DETECTED TO BE COMING FROM THE VENT PORT, WHICH CAUSED THE ALARM. THE CAUSE OF VENT VALVE MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: 061016M. SYMPTOM: HELIUM LEAK. FINDINGS / ACTION TAKEN: PCS ASSEMBLY REPLACED. PUMP CHECKED: PASS. SOFTWARE: 2.24FR. FCN: 1416. REASON FOR SERVICE: OTHER REASON. RESULTS: OPERATIONAL. PER THE TECHNICIAN SAV CONTRE PULSION IN (B)(6): "THE ERROR WAS REPORTED BY THE USER DEPARTMENT WHEN USED ON PATIENTS WITHOUT MORE INFORMATION FROM PATIENT'S CONDITION. THE PUMP WAS REPLACED BY ANOTHER PUMP. THE HOSPITAL DID NOT FILE COMPLAINTS".

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: HELIUM LEAK. FINDINGS / ACTION TAKEN: PCS ASSEMBLY REPLACED. PUMP CHECKED: PASS. SOFTWARE: 2.24FR. FCN: 1416. REASON FOR SERVICE: OTHER REASON. RESULTS: OPERATIONAL. PER THE TECHNICIEN (B)(6): "THE ERROR WAS REPORTED BY THE USER DEPARTMENT WHEN USED ON PATIENTS WITHOUT MORE INFORMATION FROM PATIENT'S CONDITION. THE PUMP WAS REPLACED BY ANOTHER PUMP. THE HOSPITAL DID NOT FILE COMPLAINTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429409 AUTOCAT2 WAVE FRENCH INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001052227

    Patients

    Seq Age Sex Outcome Treatment
    1