BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 3535415 · Received October 29, 2013

    Report

    Report Number
    1219856-2013-00260
    Event Type
    Malfunction
    Date Received
    October 29, 2013
    Date of Event
    October 2, 2013
    Report Date
    October 2, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SENIOR MANAGER, GLOBAL CLINICAL SALES (GCS) REC'D A CALL FROM AN RN IN THE CATH LAB. THEY HAD INSERTED A FOS CATHETER, BUT COULD NOT GET AN AP WAVEFORM FROM THE FOS OR TRANSDUCER. THE IAB WAS INSERTED VIA THE FEMORAL ARTERY. THE LIGHT BULB FOR THE FOS ICON WAS BLACK WITH A BLUE BACKGROUND. THE GCS ASKED THE RN TO REMOVE THE SLIDE CONNECTOR TO SEE IF THE SENSOR WAS RECESSED AND THE RN STATED IT WAS NOT. THE GCS ASKED THE RN TO RE-INSERT THE CONNECTOR; THE LIGHT BULB ON THE CONSOLE REMAINED UNCHANGED. WHEN THE RN USED THE TRANSDUCER HE GOT A MESSAGE "AP WAVEFORM UNAVAILABLE" AND HE WAS UNABLE TO ZERO. THE RN TOLD THE GCS THAT HE TRIED SWITCHING TRANSDUCER CABLES WITHOUT LUCK. THE RN SAID THAT THERE WAS ANOTHER PUMP AND WONDERED IF HE COULD SWITCH OUT THE PUMP; THE GCS AGREED. THE RN ATTACHED THE FOS AND CA1 KEY TO THE NEW PUMP. THE CATHETER STILL REMAINED UNRECOGNIZED, WITH THE BLACK LIGHT BULB. THE RN TOLD THE GCS THAT THE PUMP AUTOMATICALLY MOVED TO TRANSDUCER. THE RN HAD A WAVEFORM AND SUCCESSFULLY ZEROED THE CATHETER. GCS CALLED TO FOLLOW UP. THE GCS SPOKE TO A DIFFERENT RN IN THE CSICU. THE RN TOLD THE GCS THAT THE PATIENT WAS CURRENTLY STILL IN THE OPERATING ROOM AND THAT SHE WAS UNAWARE OF ANY ISSUES. THE PATIENT OUTCOME IS PATIENT TO OPERATING ROOM FOR BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556019 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRA-AORTIC BALLOON