BEUDAMED
    FDA Adverse Event Other Summary report: N

    BMR1900L PH W/O SAT CRIT SUBASSEMBLY

    MDR report key: 3767706 · Received April 11, 2014

    Report

    Report Number
    1718850-2014-00107
    Event Type
    Other
    Date Received
    April 11, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 17, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    PMA / PMN Number
    K112771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE BMR1900L PH W/O SAT CRIT SUBASSEMBLY. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE INLET PORT OF THE BMR VENOUS RESERVOIR BAG BROKE OFF WHEN THE CLINICIAN WAS BREAKING DOWN THE CIRCUIT UPON COMPLETION OF THE CASE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221577 BMR1900L PH W/O SAT CRIT SUBASSEMBLY RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA