BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD INTRA AORTIC BALLOON PUMP

    MDR report key: 447114 · Received March 7, 2003

    Report

    Report Number
    MW1027772
    Event Type
    Malfunction
    Date Received
    March 7, 2003
    Date of Event
    January 21, 2002
    Report Date
    February 25, 2003
    Manufacturer
    BARD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED THROUGH ER WITH ACTIVE RESPIRATORY DISTRESS. HISTORY OR DILATED CARDIO MYOPATHY, CHF, CHRONIC PULMONARY HEART DISEASE, BRONCHITIS, AND SINUSITIS. IN CATH LAB PT HAD A MARKED ELEVATED END-DIASTOLIC PRESSURE NECESSITATING THE INSERTION OF AN INTRA-AORTIC BALLOON PUMP. IABP SCREEN WENT BLANK AND PUMP SHUT OFF ABRUPTLY. THIS OCCURRED AFTER THE PT'S FAMILY MEMBER USED THEIR CELL PHONE IN THE PT'S ROOM. STAFF UNABLE TO RESUME IABP FUNCTION. SWITCHED WITH CATH LAB IABP. THREE DAYS LATER PT TRANSFERRED TO ANOTHER INSTITUTION FOR FURTHER CARE BY THEIR CARDIAC PHYSICIANS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR IN 04/29/2003: THIS PRODUCT WAS NOT MANUFACTURED BY BARD ACCESS SYSTEMS OR ANY OTHER DIVISION OF CR BARD, INC. IT HAS BEEN IDENTIFIED AS A PRODUCT FROM ARROW INTERNATIONAL. ARROW HAS BEEN NOTIFIED AND THE MED WATCH WAS FAXED TO THEIR COMPLAINT DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD INTRA AORTIC BALLOON PUMP BALLOON PUMP DSP BARD H-800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR