BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1040762 · Received May 9, 2008

    Report

    Report Number
    1219856-2008-00224
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: PER FIELD SERVICE REPORT PUMP WAS SENT TO BIOMED. BIOMED CHECKED THE FIBEROPTIX SENSOR (FOS) PER THE FOS KIT PREVIOUSLY PURCHASED AND THE FOS TESTER KIT. THE PUMP CHECKED OUT FINE AND WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    INFO WAS RECEIVED BY CALL REPORT. CLINICIAN STATED SHE HAD A PATIENT (PT) RECEIVED FROM CATH LAB WITH A FIBEROPTIX SENSOR (FOS) CATHETER IN PLACE. THERE WAS NO WAVEFORM ON THE PUMP, SO THEY WERE CURRENTLY USING TRANSDUCER. CLINICIAN STATED CATH LAB HAD ZEROED FOS & IT WAS FINE IN LAB. WHEN THEY BROUGHT PT TO UNIT, THEY HAD NO FOS. CLINICAL ON CALL (COC) ASKED HER TO GO TO FOS. FOS ICON WAS BLUE, BUT NO WAVEFORM. SHE ASKED HER TO GO TO HOME & SHOW STATUS, BUT SHE WAS UNABLE TO SEE INFO BECAUSE THERE WAS A GREEN BOX THAT STATED TO WAIT WHILE FOS CAL WAS BEING LOADED. CATHETER WAS ALREADY IN PT, BUT PUMP WAS UNABLE TO ZERO BECAUSE A WAVEFORM WAS PRESENT. COC HAD CLINICIAN DISCONNECT & RECONNECT BLUE FOS & CAL KEY. COC HEARD PUMP MAKE CONNECTION, BUT MESSAGE "LOADING CAL INFO" CAME BACK. THERE WAS STILL NO WAVEFORM PRESENT ON SCREEN. SHE TRIED TO CAL FOS, BUT IT WOULD NOT WORK. COC TOLD CLINICAL SHE NOW HAD TWO OPTIONS. SHE COULD CONTINUE TO JUST USE TRANSDUCER ON PT OR THEY COULD TRY CONNECTING FOS TO A SECOND PUMP & SEE IF THEY COULD GET A WAVEFORM. CLINICIAN STATED THEY WOULD HAVE TO GET ANOTHER PUMP FROM CATH LAB SO THAT WOULD TAKE A LITTLE TIME. COC STATED, SHE WOULD CALL BACK IN 20 MINUTES. COC CALLED BACK AND THEY HAD OBTAINED A SECOND PUMP. SHE HAD CLINICIAN CONNECT FOS BLUE SENSOR AND CAL KEY TO SECOND PUMP. COC HEARD CONNECTION AND THEY GOT A WAVEFORM. PUMP THEN STATED, IT COULD NOT AUTO ZERO SINCE A WAVEFORM WAS PRESENT. SINCE THEY NOW HAD A FOS SIGNAL, COC HAD HER CONNECT GAS DRIVE TUBING AND START PUMPING. SHE THEN HAD HER SWITCH OVER TRANSDUCER AND ECG. COC THEN COACHED HER THROUGH THE FOS CAL. EVERYTHING WAS FUNCTIONING PROPERLY AT PRESENT. CLINICIAN STATED THIS WAS SECOND TIME THEY HAD THAT TYPE OF ISSUE. SHE WAS TOLD TO TAG THIS PUMP AND SEND IT TO BIOMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK