BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE JAPANESE

    MDR report key: 6332943 · Received February 15, 2017

    Report

    Report Number
    1219856-2017-00015
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    November 12, 2016
    Report Date
    January 19, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TELEFLEX RECEIVED THE DEVICE FOR ANALYSIS. THE REPORTED COMPLAINT OF "UNABLE TO START PUMPING" IS CONFIRMED. THE PUMP ALARMED PURGE FAILURE (5) DURING FUNCTIONAL TESTING. THE VENT VALVE (V1) WAS FOUND TO BE FAULTY, WHICH IS THE ROOT CAUSE OF THE REPORTED COMPLAINT. THE ROOT CAUSE OF THE VENT VALVE FAILURE IS UNDETERMINED. 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. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING CLINICAL PRACTICE. WHEN STARTING THE PUMPING AFTER CONNECTING THE BALLOON (THE BALLOON WAS NOT INSERTED IN A PATIENT AND NO PATIENT INVOLVEMENT), THE PUMPING STOPPED SOON AFTER THE BALLOON INFLATING AND DEFLATING ONLY ONE TIME. THEN THE USER SWITCHED THE POWER ON AND OFF SEVERAL TIMES AND THE PUMP RECOVERED. THE USER COMMENTED THAT THE SAME ISSUE HAS BEEN SEEN EVERY TIME THEY USED FOR THREE YEARS, SINCE THE PUMP WAS SUPPLIED TO THE HOSPITAL. HOWEVER THEY HAD NOT BROUGHT THEM UP AS COMPLAINTS UNTIL THIS ISSUE HAPPENED BECAUSE THEY HAD BEEN THINKING THAT WAS THE MECHANICAL PROPERTY OF THE PUMP. THIS TIME THE DEALER'S PERSON REPLACED TWO PIECES OF PART '96-3006-001W' AND '77-3007-001' NEW ONES. WE COLLECTED THESE TWO PARTS AND THE USER IS REQUESTING THE INVESTIGATION FOR THEM. ACCORDING TO THE DEALER'S TECHNICIAN, THIS ALLEGED ISSUE WAS NOT REPLICATED WITH THE SIMULATOR DEVICE. ADDITIONAL INFORMATION RECEIVED: THE EVENT OCCURRED AFTER THE INTRA-AORTIC BALLOON (IAB) AND PUMP WERE PLACE ON THE PATIENT. THE SIMULATOR TEST WAS PERFORMED USING THIS PUMP AND SIMULATION IAB CATHETER. THE ISSUE WAS RESOLVED BY TURNING THE INTRA-AORTIC BALLOON PUMP (IABP) OFF AND ON AGAIN. THERE WERE NO HEALTH INJURY REGARDING THE PREVIOUS ISSUES; HOWEVER THERE WAS, ABOUT A 15 MINUTE DELAY IN THERAPY WHEN USING THIS IABP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING CLINICAL PRACTICE. WHEN STARTING THE PUMPING AFTER CONNECTING THE BALLOON (THE BALLOON WAS NOT INSERTED IN A PATIENT AND NO PATIENT INVOLVEMENT), THE PUMPING STOPPED SOON AFTER THE BALLOON INFLATING AND DEFLATING ONLY ONE TIME. THEN THE USER SWITCHED THE POWER ON AND OFF SEVERAL TIMES AND THE PUMP RECOVERED. THE USER COMMENTED THAT THE SAME ISSUE HAS BEEN SEEN EVERY TIME THEY USED FOR THREE YEARS, SINCE THE PUMP WAS SUPPLIED TO THE HOSPITAL. HOWEVER THEY HAD NOT BROUGHT THEM UP AS COMPLAINTS UNTIL THIS ISSUE HAPPENED BECAUSE THEY HAD BEEN THINKING THAT WAS THE MECHANICAL PROPERTY OF THE PUMP. THIS TIME THE DEALER'S PERSON REPLACED TWO PIECES OF PART '96-3006-001W' AND '77-3007-001' NEW ONES. WE COLLECTED THESE TWO PARTS AND THE USER IS REQUESTING THE INVESTIGATION FOR THEM. ACCORDING TO THE DEALER'S TECHNICIAN, THIS ALLEGED ISSUE WAS NOT REPLICATED WITH THE SIMULATOR DEVICE. ADDITIONAL INFORMATION RECEIVED: THE EVENT OCCURRED AFTER THE INTRA-AORTIC BALLOON (IAB) AND PUMP WERE PLACE ON THE PATIENT. THE SIMULATOR TEST WAS PERFORMED USING THIS PUMP AND SIMULATION IAB CATHETER. THE ISSUE WAS RESOLVED BY TURNING THE INTRA-AORTIC BALLOON PUMP (IABP) OFF AND ON AGAIN. THERE WERE NO HEALTH INJURY REGARDING THE PREVIOUS ISSUES; HOWEVER, THERE WAS, ABOUT A 15 MINUTE DELAY IN THERAPY WHEN USING THIS IABP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116147 AUTOCAT2 WAVE JAPANESE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001200141

    Patients

    Seq Age Sex Outcome Treatment
    1