BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLMBUS REG HSP CLMBUS IN1

    MDR report key: 1020920 · Received March 28, 2008

    Report

    Report Number
    1718850-2008-00005
    Event Type
    Death
    Date Received
    March 28, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 28, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SMARXT OPTIMA XP OXYGENATOR MANUFACTURED BY SORIN GROUP USA, INC. IS A COMPONENT IN THE CUSTOM PERFUSION PACK MANUFACTURED BY SORIN GROUP USA, INC. THE CUSTOM PERFUSION PACK, CATALOG NUMBER 067481003, IS A PRE-AMENDMENT DEVICE. ONE SMARXT OPTIMA XP OXYGENATOR WAS RETURNED TO SORIN GROUP USA, INC. FOR EVAL. VISUAL INSPECTION OF THE OXYGENATOR REVEALED NO DEFECTS. BLOOD SIDE AND GAS SIDE INTEGRITY TESTING WAS RUN AT VARYING FLOW RATES. NO LEAKS WERE FOUND WITH THE UNIT AND THERE WERE NO OBSTRUCTIONS IN THE BLOOD OR GAS SIDE PATHWAYS. A REVIEW OF THE MFG RECORDS INDICATED THAT THE OXYGENATOR WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE DEVICE WAS CONNECTED TO A CIRCUIT AND TESTED OVER TIME AT A BLOOD FLOW RATE OF 4.5 LPM AND GAS TO BLOOD FLOW RATE OF 1:1. THE TEST WAS REPEATED AT A GAS TO BLOOD FLOW RATE OF 2:1. NO FROTH OR AIR WAS DETECTED AT ANYTIME DURING THE TESTING. THE SURGEON REPORTED THAT THE OXYGENATOR LOOKED NORMAL, THERE WERE NO CRACKS IN THE CASING, NO BLOCKAGE OF THE VENT PORTS AND NO OBVIOUS FIBER FRACTURES. LAB TESTING FOUND THAT THE OXYGENATOR PERFORMED NORMALLY. THE REPORTED FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    TWO MINS INTO BYPASS, THE OXYGENATOR SYSTEM SUDDENLY FILLED WITH APPROX 400-500 MLS OF AIR, EXHIBITING FROTHING AROUND THE ARTERIAL LINE. THE SURGEON REPORTED, THAT THE OXYGENATOR HAD FILLED WITH AIR, ORIGINATING FROM THE GAS LINE. THE OXYGENATOR WAS CHANGED OUT AND BYPASS CONTINUED. THE PT EXPIRED HRS LATER IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLMBUS REG HSP CLMBUS IN1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA 0617800010

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death