BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 6307565 · Received February 7, 2017

    Report

    Report Number
    1219856-2017-00018
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 13, 2017
    Report Date
    January 13, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT OF "BLOOD BACKUP INTO THE PUMP" WAS CONFIRMED BY THE FIELD SERVICE REPRESENTATIVE. NO IAP PARTS OR RECORDER STRIPS WERE RETURNED FOR EVALUATION TO TELEFLEX DUE TO BLOOD CONTAMINATION. NO IAB RUPTURES WERE REPORTED. THE ROOT CAUSE OF THE BLOOD BACKING UP INTO THE PUMP IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: PUMP HAD BLOOD BACKUP. FINDINGS/ACTION TAKEN: PARTS FOR BLOOD DECONTAMINATION SENT TO AND REPLACED BY HOSPITAL BIOMED FCN LEVEL: 1416. SOFTWARE LEVEL: 2.24. EXPEDITED QA REVIEW: YES. OP = ON PATIENT. CONFIRMED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA A FIELD SERVICE REPORT: L611447. SYMPTOM: PUMP HAD BLOOD BACKUP. FINDINGS/ACTION TAKEN: PARTS FOR BLOOD DECONTAMINATION SENT TO AND REPLACED BY HOSPITAL BIOMED. FCN LEVEL: 1416. SOFTWARE LEVEL: 2.24. EXPEDITED QA REVIEW: YES. OP = ON PATIENT. CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90330 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1