BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1883079 · Received October 15, 2010

    Report

    Report Number
    1219856-2010-00733
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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 INSERTION SITE WAS THE PT'S RIGHT FEMORAL ARTERY. THE PT WAS MOVED TO THE ICU. THE RN IN THE ICU PLACED A CALL TO THE CLINICAL SUPPORT SPECIALIST (CSS) STATING THAT "THE PUMP HAD RECURRING HELIUM LOSS (2) ALARMS." THE RN SAID "THE PUMP CONTINUED TO STOP PUMPING WITH HELIUM LOSS (2) ALARMS & THEY ARE UNABLE TO FIND CAUSE." THE RN STATED THAT THE IAB DOES NOT HAVE A KINK & REPOSITIONING DOES NOT CHANGE ALARM; THERE IS NO BLOOD NOTED IN TUBING. THE RN STATED THAT THEY HAVE TRIED ALL TROUBLESHOOTING, INCLUDING DECREASING HELIUM VOLUME & DECREASING ASSIST RATIO TO 1:2 WITH NO CHANGE. THE CSS TOLD THE RN THAT "THE HELIUM LOSS (2) ALARMS" TYPICALLY HAPPEN WITH BALLOON ABRASIONS THOUGH SAME SET OF CAUSES CAN IN FACT CAUSE EITHER HELIUM (2) OR (3) ALARMS." THE CSS TOLD THE RN THAT "IT IS STILL POSSIBLE TO HAVE AN ABRASION, BUT NOT YET SEE BLOOD IN THE TUBING & IF SHE FELT SHE EXHAUSTED ALL OTHER POSSIBILITIES, THEY MAY WANT TO CONSIDER AN ABRASION." THE RN NOTIFIED THE PHYSICIAN. IN THE MEANTIME, A LEAK TEST WAS PERFORMED WITH A DROP IN BASELINE, INDICATING A LEAK IN THE CONSOLE. THE CONSOLE WAS REMOVED & EXCHANGED FOR A DIFFERENT CONSOLE & THE ALARMS CEASED. THE LENGTH OF TIME PRIOR TO THIS EVENT IS LISTED AS 3 1/2 HRS. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A DELAY/INTERRUPTION IN IAB THERAPY. THE TIME FRAME OF THE DELAY IS THE TIME IT TOOK TO EXCHANGE THE PUMP. THERE WERE NO REPORTED PT COMPLICATIONS. THE OUTCOME OF THE PT IS "UNCHANGED." PUMP WAS SENT TO BIOMED.

    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 UNKNOWN INTRA-AORTIC BALLOON