BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 6080171 · Received November 4, 2016

    Report

    Report Number
    1219856-2016-00249
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) THE REPORTED ALARM COULD NOT BE REPLICATED AT TELEFLEX (B)(4); HOWEVER, EXCESSIVE NOISE WAS NOTED AND THE PUMP ALARMED SYSTEM ERROR 3 APPROXIMATELY 2 HOURS AFTER INITIATING PUMPING. THERE WAS NO REPORTED PATIENT INJURY OR COMPLICATIONS. TELEFLEX WILL CONTINUE TO MONITOR FOR ANY DEVELOPING TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT # (B)(4). SYMPTOM: PUMP HAS INTERMITTENT HIGH BASELINE ALARMS ON PATIENT. PUMP WAS SWITCHED OUT QUICKLY WITH NO COMPLICATIONSFINDINGS/ACTION TAKEN: REPLACED PUMP ASSY. RETURNING ON (B)(4). ALSO PERFORM PEVENTATIVE MAINTENCE (PM). FCN LEVEL: (B)(4). SOFTWARE LEVEL: 2.24 OP = ON PATIENT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT # L611391. SYMPTOM: PUMP HAS INTERMITTENT HIGH BASELINE ALARMS ON PATIENT. PUMP WAS SWITCHED OUT QUICKLY WITH NO COMPLICATIONS FINDINGS/ACTION TAKEN: REPLACED PUMP ASSY. RETURNING ON AR# (B)(4). ALSO PERFORM PREVENTATIVE MAINTENANCE (PM). FCN LEVEL: 1416, SOFTWARE LEVEL: 2.24, OP = ON PATIENT, CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729346 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 0001117068

    Patients

    Seq Age Sex Outcome Treatment
    1