BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET

    MDR report key: 1982536 · Received February 4, 2011

    Report

    Report Number
    1718850-2011-00001
    Event Type
    Other
    Date Received
    February 4, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K974897
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION WAS REQUESTED, BUT NOT PROVIDED BY THE FACILITY. A F/U REPORT WILL BE FILED IF THIS INFORMATION IS REC'D. EXPIRATION DATE: WITHOUT THE LOT NUMBER, THE EXPIRATION DATE IS UNK. WITHOUT THE LOT NUMBER, THE MANUFACTURING DATE IS UNK. SORIN GROUP (B)(4) MANUFACTURES THE BRAT 2 PROCESSING SET. THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A USER MEDWATCH REPORT, (B)(4), WAS REC'D ON (B)(4) 2011 INDICATING THAT THERE WAS A FAILURE OF THE CELL SALVAGE CENTRIFUGE AND BOWL GASKET. FURTHER COMMUNICATION WITH THE FACILITY'S BIOMEDICAL ENGINEER REVEALED THAT THE ISSUE ACTUALLY INVOLVED ONLY THE DISPOSABLE BRAT BOWL. THE BIOMEDICAL ENGINEER STATED THAT IT WAS MOST LIKELY A SEAL FAILURE ON THE BOWL AND THAT A LINE MAY HAVE BEEN CLAMPED. THE DISPOSABLE INVOLVED IN THE ISSUE WAS DISCARDED BY THE USER AND THEREFORE, WAS NOT AVAILABLE FOR EVALUATION. NO ROOT CAUSE COULD BE DETERMINED WITH THE AVAILABLE INFORMATION. THE MEDWATCH REPORT, (B)(4), DID NOT INDICATE THAT THERE WAS ANY PT INJURY. INFORMATION RELATED TO THE EXTENT OF PT INVOLVEMENT WAS REQUESTED BUT NO RESPONSE HAS BEEN REC'D TO DATE. A F/U REPORT WILL BE FILED IF THIS INFORMATION IS REC'D. NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP ITALIA NA

    Patients

    Seq Age Sex Outcome Treatment
    1