BEUDAMED
    FDA Adverse Event Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2112488 · Received April 4, 2011

    Report

    Report Number
    1124841-2011-00153
    Date Received
    April 4, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTR
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    MA-2011-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IS NOT BEING RETURNED TO TERUMO; HOWEVER, STILL PLANS TO INVESTIGATE THE ISSUE. TERUMO WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE CARDIOVASCULAR PROCEDURE KIT LEAKED AT THE LUER CONNECTION WHEN THE LINES WERE PRESSURIZED. THE USER FACILITY REPORTED MULTIPLE OCCURRENCES ON DIFFERENT DATES; HOWEVER, EVENT INFORMATION WAS ONLY PROVIDED FOR ONE OCCURRENCE. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PT INVOLVEMENT, AS THE EVENT OCCURRED DURING PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CARDIOVASCULAR PROCEDURE KIT DTR TERUMO CARDIOVASCULAR SYSTEMS CORP. NA MG21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK