BEUDAMED
    FDA Adverse Event Other Summary report: N

    SC MORRISTOWN MORRISTOWN NJ 2

    MDR report key: 3855580 · Received May 28, 2014

    Report

    Report Number
    1718850-2014-00167
    Event Type
    Other
    Date Received
    May 28, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 1, 2014
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    KRI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT OF INADEQUATE FLOW THROUGH THE HEART LUNG PACK CIRCUIT DURING THE FIRST SEVERAL MINS AFTER GOING ONTO BYPASS. THE PT HAD NOT YET BEEN COOLED BUT WAS ON VENTILATION. A NEW HEART LUNG MACHINE WITH A DISPOSABLES CIRCUIT WAS BROUGHT IN. THE PT WAS PLACED BACK ON BYPASS. THE CASE PROCEEDED AND WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314753 SC MORRISTOWN MORRISTOWN NJ 2 CUSTOM PERFUSION PACK KRI SORIN GROUP USA, INC. NA 1405800047

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR