BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 3002088 · Received February 12, 2013

    Report

    Report Number
    1219856-2013-00028
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 19, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CATH LAB RN CALLED BECAUSE THEY HAD RECEIVED AN "FOS (FIBEROPTIX SENSOR) OUT OF RANGE" ALARM IMMEDIATELY UPON INSERTION OF THE FOS CONNECTOR AND THE RN STATED THAT IT ALSO SAID "FOS WARNING." ACCORDING TO THE RN, THE PT WAS NOT CRITICAL, SO THEY OPENED A SECOND IAB AND TRIED A SECOND PUMP AND IT ALARMED "FOS OUT OF RANGE." AT THIS TIME, THE RN WAS ABLE TO CALIBRATE THE FOS AFTER INSERTION. THE RN TOLD THE CLINICAL SUPPORT SPECIALIST (CSS) THAT SHE DID NOT ATTEMPT TO MANUALLY ZERO THE FOS PRIOR TO INSERTION. THE PT IS NOW IN THE INTENSIVE CARE UNIT (ICU) AND THE CSS VERIFIED THAT THE SECOND PUMP WAS CURRENTLY PUMPING AND SUPPORTING THE PT WELL. PER THE RN, THE PUMP WAS PROVIDING GOOD SUPPORT UTILIZING THE FOS FOR THE ARTERIAL PRESSURE (AP) SOURCE. THE RN WAS CALLING TO SEE IF THEY NEED TO HAVE THEIR PUMPS CHECKED OUT. THE CSS EXPLAINED THAT THE SHOULD HAVE A FOS TESTER IN BIOMED AND THEY CAN CHECK THE PUMPS WITH THE FOS TESTERS. THE CSS ALSO MENTIONED THAT THIS IS NOT EMERGENT AND THEY CAN CHECK THE PUMP IN USE AFTER IT IS DISCONTINUED. AN UPDATE RECEIVED ON (B)(4) 2012 STATED THAT ACCORDING TO THE CATH LAB RN THE PUMP WAS PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61308 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON