BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 1981041 · Received February 2, 2011

    Report

    Report Number
    1124841-2011-00014
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K020998
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL. VISUAL INSPECTION NOTED NO ANOMALIES. THE COMPLAINT SAMPLE WAS MEASURED, AND INLET BARB DIAMETERS FELL WITHIN TCVS SPECIFICATIONS. PULL TESTING WAS PERFORMED TO DETERMINE TIE-BANDED X-COATED TUBING DISCONNECT FORCE, AND THE SAMPLE MET SPECIFICATIONS. THE TUBING THE CUSTOMER USED AND CONNECTION MADE MAY HAVE CONTRIBUTED TO THE DISCONNECT ISSUE; HOWEVER, THE DISCONNECTION DID CAUSE THE PT TO HAVE ONE LITER OF BLOOD LOSS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYS, THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE TUBING SLIPPED OFF THE BARBS OF THE CENTRIFUGAL PUMP. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PT HAS HAD NO ADVERSE REACTION AND IS RECOVERING. THERE WAS ONE LITER OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. NA MG28

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention