BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE PRECISION BLOOD PUMP

    MDR report key: 1979329 · Received January 25, 2011

    Report

    Report Number
    1718850-2010-00184
    Event Type
    Other
    Date Received
    January 25, 2011
    Manufacturer
    COBE CARDIOVASCULAR, INC (NOW SORIN GROUP USA)
    Product Code
    DWA
    PMA / PMN Number
    K77002
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP USA, RECEIVED A USER MEDWATCH REPORT #((B)(4)) STATING THAT WITHOUT ANY INDICATION OR ALARM, THE ECMO PUMP STOPPED. THE PT WAS IMMEDIATELY CLAMPED OFF. THE PUMP WAS RESTARTED AND THE PT WAS PLACED BACK ON ECMO. RISK MGMT WAS CONTACTED. THERE WAS NO REPORT OF PT INJURY AS A RESULT OF THE INCIDENT. THE HOSP CONTRACTED AN OUTSIDE ENGINEERING SERVICE TO EVALUATE THE PUMP. THE PUMP WAS PLACED OUT OF SERVICE AND THE CONTRACT ENGINEER DISPATCHED TO EVALUATE THE PUMP. IT WAS DETERMINED THAT THE MOTOR CONTROL BOARD HAD MALFUNCTIONED. THE ENGINEER REPLACED THE CONTROL BOARD. THE PUMP WAS TESTED AND PASSED ALL SPECS. THE PRECISION BLOOD PUMP WAS ORIGINALLY MFG BY COBE CARDIOVASCULAR, INC (NOW SORIN GROUP USA). THIS PRODUCT LINE HAS BEEN DISCONTINUED AND IS NO LONGER DISTRIBUTED OR SERVICED BY SORIN GROUP USA. THERE WAS NO PT INJURY. NO OTHER PROBLEMS WERE FOUND BY THE CONTRACT ENGINEER. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE PRECISION BLOOD PUMP ROLLER-TYPE CARDIOPULMONARY BYPASS BLOOD PUMP DWA COBE CARDIOVASCULAR, INC (NOW SORIN GROUP USA)

    Patients

    Seq Age Sex Outcome Treatment
    1