BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARY HITCHCOCK HANOVER NH 1

    MDR report key: 2835361 · Received November 7, 2012

    Report

    Report Number
    1718850-2012-01049
    Event Type
    Other
    Date Received
    November 7, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE WILL BE PROVIDED ON THE FOLLOW UP REPORT. SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR, WHICH IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510(K) NUMBER OF THE PRIM O2X OXYGENATOR IS K050047. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE THE PERFUSIONIST EXPERIENCED INADEQUATE CO2 GAS EXCHANGE. THERE WAS NO PATIENT IMPACT. THE DEVICE WAS RETURNED TO SORIN GROUP FOR EVALUATION. THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING THE PROCEDURE THE PERFUSIONIST EXPERIENCED INADEQUATE CO2 GAS EXCHANGE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARY HITCHCOCK HANOVER NH 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP