BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2241179 · Received August 17, 2011

    Report

    Report Number
    1219856-2011-00295
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 8, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED IN THE CATH LAB. THE PT WAS TO BE TRANSFERRED TO ANOTHER HOSPITAL. THE TRANSPORT TEAM WAS TAKING THE PT FROM THE AMBULANCE INTO THE HOSPITAL AND AT THAT TIME THE PUMP ALARMED LOW BATTERY WITH 20 MINS. THE PUMP ALARMED AGAIN DISPLAYING 10 MINS; HOWEVER, THE TECHNICIANS BELIEVE THE PUMP SHUT OFF SOONER THEN 10 MINS. THE IAB WAS CONNECTED TO ONE OF THE HOSPITALS' PUMPS AND THE IAB THERAPY CONTINUED. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WAS DELAYED FOR THE TIME IT TOOK TO SWITCH THE PUMP. THERE WERE NO PT COMPLICATIONS AND THE PT OUTCOME IS LISTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK