BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CARDIOTOMY RESERVOIR

    MDR report key: 2080941 · Received April 13, 2011

    Report

    Report Number
    1124841-2011-00169
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTN
    PMA / PMN Number
    K033800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION AND VISUAL INSPECTION CONFIRMED THE CRACKED LID ON THE RESERVOIR. THIS TYPE OF DAMAGE IS MOST LIKELY CAUSED BY EXCESSIVE FORCE APPLIED TO THE UNIT DURING POST MFG HANDLING. (B)(4). A REVIEW OF THE COMPLAINT FILES COULD NOT CONFIRM THAT THERE HAVE BEEN PREVIOUS REPORTS FOR THIS LOT. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MGMT FOR APPROPRIATE TRACKING, TRENDING AND F/U.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, THEY NOTICED A CRACK AT THE TOP OF THE RESERVOIR AFTER CHANGING IT OUT. THE PRODUCT WAS CHANGED OUT. THERE WAS MINIMAL BLOOD LOSS. THERE WAS NO HARM TO PT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX CARDIOTOMY RESERVOIR BLOOD RESERVOIR DTN TERUMO CARDIOVASCULAR SYSTEMS CORP. NA MP21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK