BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST. JOSEPH HSP BALTIMORE MD1

    MDR report key: 1856607 · Received October 1, 2010

    Report

    Report Number
    1718850-2010-00155
    Event Type
    Other
    Date Received
    October 1, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 1, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPIRATION DATE IS UNK. THE MANUFACTURING DATE IS UNK. SORIN GROUP (B)(4) MANUFACTURES THE CSC14 CARDIOPLEGIA DEVICE. THE 510(K) NUMBER IS K012898. THE CSC14 IS A COMPONENT OF THE HEART LUNG PACK. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). IT WAS REPORTED THAT DURING BYPASS THE PERFUSIONIST NOTICED AIR BUBBLES IN THE OUTLET OF THE CARDIOPLEGIA LINE. THE AIR WAS DIVERTED AND DID NOT REACH THE PT. THE UNIT WAS USED TO COMPLETE THE CASE. THE INVESTIGATION IS ON-GOING. A F/U REPORT WILL BE FORWARDED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BYPASS THE PERFUSIONIST NOTICED AIR BUBBLES IN THE OUTLET OF THE CSC14 CARDIOPLEGIA LINE. THE AIR WAS DIVERTED AND DID NOT REACH THE PT. THE UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JOSEPH HSP BALTIMORE MD1 HEART LUNG PACK DWF SORIN GROUP USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1