BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE ITALIAN

    MDR report key: 5837983 · Received August 1, 2016

    Report

    Report Number
    1219856-2016-00162
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 5, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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 ABNORMALITIES WERE NOTED. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE PUMP ALARMED PURGE FAILURE (5) IMMEDIATELY AFTER PUMPING WAS INITIATED. THE KNOWN GOOD AUTOCAT2W WITH THE PCS ASSEMBLY IN QUESTION INSTALLED FAILED THE FUNCTIONAL TEST. THE PCS ASSEMBLY WAS THEN REMOVED FROM THE PUMP. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED ONTO THE MDT-50 LEAK TESTER AND FAILED LEAK TESTING. LEAK WAS NOTED TO BE COMING FROM THE DRAIN PORT. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED. DEBRIS AND DRIED BLOOD WERE FOUND INSIDE THE DRAIN VALVE AND MANIFOLD BLOCK WHERE THE DRAIN VALVE CONNECTED TO. NOTICE: THE PURGE FAILURE ALARM WOULD OCCUR IF SYSTEM COULD NOT PULL A NEGATIVE PRESSURE (DRAIN VALVE). THIS IS AN ORIGINAL PCS ASSEMBLY, AND THIS 2008 IABP. SEE OTHER REMARKS SECTION. OTHER REMARKS: 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 "POSSIBLE HELIUM LOSS ALARM" IS CONFIRMED BASED OFF THE LEAKAGE FROM THE DRAIN PORT DURING LEAK TESTING. THE PUMP ALARMED PURGE FAILURE (5) WHEN PUMPING WAS INITIATED. DEBRIS AND DRIED BLOOD WERE FOUND INSIDE THE DRAIN VALVE AND THAT CAUSED THE REPORTED COMPLAINT. THE ROOT CAUSE OF HOW THE BLOOD ENTERED THE DRAIN VALVE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA AN EQR REPORT. SYMPTOM: PCS HAS A LEAKAGE AND POSSIBLE HELIUM LEAKAGE ALARM WAS DISPLAYED DURING THERAPY THE PHYSICIAN SWITCHED IAP HAVING MORE THAN ONE AVAILABLE, NO PROBLEM FOR THE PATIENT. ACTIONS: PCS HAS BEEN REPLACED ACCORDING TO HIGH STANDARD SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA AN EQR REPORT SYMPTOM: PCS HAS A LEAKAGE AND POSSIBLE HELIUM LEAKAGE ALARM WAS DISPLAYED DURING THERAPY THE PHYSICIAN SWITCHED IAP HAVING MORE THAN ONE AVAILABLE, NO PROBLEM FOR THE PATIENT. ACTIONS: PCS HAS BEEN REPLACED ACCORDING TO HIGH STANDARD SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488353 AUTOCAT2 WAVE ITALIAN INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1