BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2922192 · Received January 16, 2013

    Report

    Report Number
    1219856-2013-00013
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2013-00012 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED VIA A CELL FROM THE TRANSPORT RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) AT 07:48 EST DUE TO THE INTRA-AORTIC BALLOON PUMP (IABP) REGISTERING 2.5 CC HELIUM AND HAVING AUGMENTATION WHEN PLACED ON THE TRANSPORT PUMP WHEN PICKING THE PT UP AT THE HOSPITAL. THE PT WAS PLACED BACK ON THE ORIGINAL PUMP FOR SUPPORT WHILE CALL WAS PLACED TO THE HOTLINE. AS A RESULT, THE PUMP WAS POWERED OFF AND ON AND DRIVELINE RECONNECTED. THE BIOMED HAD THIS ISSUE WITH THIS CUSTOMER BEFORE. THEY PLUGGED IN THE DRIVELINE AND STARTING PUMPING AT THE SAME TIME; THE PUMP DOESN'T HAVE TIME TO RECOGNIZE THE CONNECTOR PROPERLY. THE SALES REP AND FIELD SERVICE REP (FSR) WILL BE ONSITE IN THE NEXT FEW WEEKS TO REINFORCE THIS ISSUE. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE SHEATH VIA FEMORAL ARTERY WITHOUT ISSUE AT 2:00 PM THAT DAY. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY NOTED. THE PT OUTCOME IS THE PT WAS STILL RECEIVING IABP THERAPY. AN UPDATE RECEIVED ON (B)(4) 2013 FROM THE CSS STATED THAT THIS IS THE SAME PT THAT THE CSS TOOK A CALL FROM ON (B)(4) 2013 AT 3:02 PM. THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR OPEN HEART SURGERY SUCCESSFULLY. IT WAS CONFIRMED THAT THE PUMP WAS SWITCHED BACK TO THE FIRST PUMP WHILE CALLING THE HOTLINE. THE CUSTOMER, AFTER SHUTTING DOWN AND RECONNECTING, WAS ABLE TO SUCCESSFULLY INITIATE PUMPING. THIS CUSTOMER HAS BEEN INSTRUCTED BEFORE ABOUT CONNECTION SEQUENCE. THEY CONNECT THE COLOR CODED DRIVELINE CONNECTOR AT THE SAME TIME THEY INITIATE PUMPING. THE PUMP DOES NOT HAVE ENOUGH TIME TO RECOGNIZE THE CONNECTOR PROPERLY AND STAYS AT THE DEFAULT VOLUME OF 2.5 CC. THE CSS WILL BE ON SITE (B)(4) 2013 TO REVIEW AGAIN WITH THEM. THE IABP SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24561 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON