BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2686109 · Received August 6, 2012

    Report

    Report Number
    1219856-2012-00247
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    July 16, 2012
    Report Date
    August 3, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT WHILE IN THE CATH LAB AFTER INSERTION. THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA RIGHT SIDE OF PT SUCCESSFULLY. AFTER THE INSERTION WAS COMPLETE, THEY REALIZED THE PUMP WOULD NOT START, "WAS COMPLETELY OUT OF ORDER" WITH NO ALARMS. AS A RESULT, THE PT WAS URGENTLY TRANSPORTED BY HELICOPTER TO ANOTHER HOSPITAL. THE PT WAS NOT CONNECTED TO A PUMP DURING TRANSPORT. THE PT WAS SUPPORTED BY DRUGS DURING THIS TIME SUCCESSFULLY. THIS IS THE ONLY PUMP IN THIS HOSPITAL. THE PUMP IS NOT USED EVERY DAY, SO THERE IS NO DAILY CHECK ROUTINE; HOWEVER, THE PUMP IS ALWAYS CHECKED BEFORE USE. AFTER TURNING ON THE PUMP, IT DID NOT SHOW AN ERROR AND BASIC FUNCTIONS LOOKED OKAY. LATER, AFTER THE IAB WAS INSERTED, THE PUMP DID NOT START TO WORK. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS AN APPROX 2 HOUR DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PT NOTED. THE PT OUTCOME IS THE PT WAS NOT INJURED DURING TRANSPORT. THE PT WAS ABLE TO GO ON TO BYPASS SURGERY AFTER TRANSPORT. IT HAS BEEN REPORTED THAT THE PT IS IN GOOD CONDITION. THE PUMP IS IN USE SINCE (B)(4) 2005, TOTAL TIME OF ACTIVE WORK IS 5302 HOURS. THE PUMP WAS SERVICED AND REPAIRED DIRECTLY IN THE HOSPITAL, PNEUMATIC ASSEMBLY BLOCK 96-3006-001X ((B)(4)). THE PUMP IS BACK IN SERVICE AFTER BEING REPAIRED ON (B)(4)2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC KC4100453

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR INTRA-AORTIC BALLOON