BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 4640825 · Received March 27, 2015

    Report

    Report Number
    1219856-2015-00068
    Event Type
    Death
    Date Received
    March 27, 2015
    Date of Event
    March 7, 2015
    Report Date
    March 9, 2015
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA AN EMAIL FROM THE CLINICAL ENGINEER AT THE HOSPITAL AND REC'D BY THE FIELD SVC REP (FSR) THAT THE INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED ON A STEMI (SEGMENT ELEVATION MYOCARDIAL INFARCTION) PT AND SET ON THE FIBEROPTIX SENSOR (FOS) SETTING. THE PT HAD NO PULSE AND CPR WAS BEING PROVIDED. THE BALLOON WAS FUNCTIONING WHILE RECEIVING CHEST COMPRESSIONS AND SET ON FOS SETTINGS. IF CHEST COMPRESSIONS WERE STOPPED, THE BALLOON DID NOT FUNCTION AS THER WAS NO ARTERIAL WAVEFORM. EKG WIRES WERE APPLIED 1-2 MINUTES AFTER THE IABP WAS PLACED AND RUNNING. AT SOME POINT DURING CODE, THE EKG PATCHES WERE DISCONNECTED FROM THE PT. POSSIBLE CAUSES OF DISCONNECTION WERE FROM THE CHEST COMPRESSIONS, MOVING THE CATH TABLE, OR ENTANGLEMENT WITH OTHER LINES/SUPPLIES BEING USED DURING ARREST. THE IABP WAS PLACED ON INTERNAL MODE AND THE PUMP STILL DID NOT FUNCTION; THE ALARM MESSAGE APPEARED SAYING "KINK IN LINE" OR "HELIUM LOSS." THIS ALARM WOULD APPEAR IF CHEST COMPRESSIONS WERE STOPPED. "WE REMOVED THE FIRST INTRA-AORTIC BALLOON (IAB) FROM THE PT AND PLACED A NEW 40CC BALLOON AND THE SAME ALARM MESSAGES APPEARED." ADD'L INFO REC'D ON (B)(6) 2015 REPORTED THAT THERE WERE NOTED PT COMPLICATIONS. MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. CPR/ CODE WAS CALLED. THE PT DID EXPIRE. IT IS UNK IF THE DEVICE CONTRIBUTED TOWARDS THE PT DEATH. IT WAS REPORTED PER FSR: SYMPTOM - PUMP HAD SEVERAL GAS ALARMS WHILE ON PT. FINDINGS/ ACTION TAKEN: PUMP CHECKED OUT OK INITIALLY. AFTER AN HOUR THERE WAS A SYS ERROR 8 ALARM AND FIBER OPTICS NO LONGER WORKED. THE FOS BOARD WAS REPLACE. THE FOS CONNECTOR WAS ALSO REPLACED DUR TO THE SENSOR NOT SLIDING EASILY. THE GAS ALARMS WERE LIKELY CAUSED BY CHEST COMPRESSIONS WHILE PUMP WAS IN INTERNAL TRIGGER. SOFTWARE LEVEL: 2.24. IT WAS NOTED BY THE FSR THAT IT WAS NOT MENTIONED IN THE FIELD SVC REPORT THAT THE RECORDER PAPER WAS INSTALLED UPSIDE-DOWN ON THE PUMP SO ALL THAT WOULD PRINT OUT WERE BLANK STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207349 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death