BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE GERMAN

    MDR report key: 2080106 · Received April 7, 2011

    Report

    Report Number
    1219856-2011-00118
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB-05840-LWS, SERIAL NUMBER (B)(4)) WAS INSERTED SUCCESSFULLY. AFTER THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY BEGAN, THE HELIUM LOSS ALERT OCCURRED. THE CATHETER WAS NOT KINKED AND BLOOD WAS NOT VISIBLE IN THE LINE. THE HELIUM LINE WAS CONNECTED CORRECTLY. NO ECTOPIC BEATS FROM PT. THE PUMP WAS ALARMING EVERY 2 MINS. AS A RESULT, THE PUMP WAS REPLACED WITH A DATASCOPE PUMP. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A REPORTED DELAY INTERRUPTION OF IABP THERAPY, DUE TO THE EXCHANGE OF THE PUMP. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS OK. ADD'L INFO RECEIVED ON (B)(4) 2011 FROM THE CLINICAL SUPPORT SALES REP STATED THAT DRY OLD BLOOD WAS FOUND IN THE CONDENSATION CONTAINER. IT IS NOTED THAT SUPPORT WAS REQUESTED BY A THIRD PARTY ORGANIZATION. REFERENCE MDR # 1219856-2011-00119 FOR THE IAB REPORT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE GERMAN INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DATASCOPE PUMP