BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER CPB SUPPORT SYSTEM

    MDR report key: 961600 · Received May 31, 2007

    Report

    Report Number
    3003793891-2006-00001
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Manufacturer
    RAND S.R.L.
    Product Code
    DWB
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ANAYSIS: PRODUCT INVESTIGATION AND OPERATIONAL INSPECTION WERE PERFORMED BY THE MEDTRONIC REP AT THE USER FACILITY. FINDINGS SHOW WE WERE ABLE TO DUPLICATE THE REPORTED PROBLEM WITH THE EXTERNAL PUMP MOTOR DRIVE AND DEEMED IT WAS DUE TO AN INTERMITTENT CONNECTION INSIDE THE PERFORMER CPB UNIT. AN EVAL OF THE RETURNED UNIT WAS PERFORMED AT MEDTRONIC AND INCLUDED MECHANICAL AND FUNCTIONAL TESTING OF THE INSTRUMENT. FINDINGS REVEALED A POOR SOLDERING CONNECTION OF AN INTERNAL GROUND WIRE WHERE THE MOTOR DRIVE CONNECTS. THE DEVICE HISTORY RECORD WAS REVIEWED BY THE MFR AND NO DISCREPANCIES WERE FOUND. CONCLUSION: NO PT INJURY. THE PRODUCT PROBLEM WAS RELATED TO A SOLDER JOINT. MEDTRONIC IS REPORTING THIS EVENT AS THE U.S. AGENT FOR THE FOREIGN MFR.

    Description of Event or Problem · 1

    INITIAL EVENT DESCRIPTION FROM THE USER REPORTED INTERMITTENT EXTERNAL MOTOR DRIVE FAILURES DURING THE CASE. DURING THE PROCEDURE, THE MOTOR STOPPED TWICE REQUIRING THE PUMP TO BE HAND CRANKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMER CPB SUPPORT SYSTEM CPB SUPPORT SYSTEM DWB RAND S.R.L. R5100052 NA

    Patients

    Seq Age Sex Outcome Treatment
    1