BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 2187540 · Received July 22, 2011

    Report

    Report Number
    1718850-2011-00084
    Event Type
    Other
    Date Received
    July 22, 2011
    Date of Event
    March 9, 2011
    Report Date
    June 24, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURED THIS SYNTHESIS OXYGENATOR. THE 510(K) NUMBER OF K022450. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) REC'D A REPORT THAT DURING BYPASS, BLOOD WAS SEEN COMING FROM THE BOTTOM OF THE OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT WITHIN THREE MINS W/O ISSUE. THERE WAS NO REPORT OF PT INJURY. THE SYNTHESIS OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR EVAL. SORIN GROUP (B)(4) LEAK TESTED THE UNIT AND CONFIRMED COMMUNICATION BETWEEN THE BLOOD AND WATER SIDE COMPARTMENTS OF THE OXYGENATOR. AUTOPSY REVEALED A HOLE IN THE STAINLESS STEEL HEAT EXCHANGER MEMBRANE. A SAMPLE WAS SENT TO AN OUTSIDE LABORATORY FOR FURTHER ANALYSIS. THE ROOT CAUSE WAS IDENTIFIED AS DEGRADATION AND CORROSION OF THE METAL SHEET OCCURRING OVER TIME AFTER PRODUCT RELEASE. DEFECTS IN THE SURFACE OF THE RAW MATERIAL AND CHEMICAL INTERACTIONS WERE IDENTIFIED AS POTENTIAL CAUSES FOR THE CORROSION. DEFECTS IN THE SURFACE OF THE RAW MATERIAL CAN OCCUR AS A RESULT OF RESIDUES GENERATED FROM (B)(4). SURFACE DEFECTS CAN ALSO OCCUR IF THERE IS IRREGULARITY (B)(4). PRODUCTION PROCESS IMPROVEMENTS AND REVISED SPECIFICATIONS HAVE BEEN IMPLEMENTED TO REDUCE THE POTENTIAL FOR SURFACE DEFECTS OF THE (B)(4) REC'D FROM THE SUPPLIER. VISUAL INSPECTION OF THE (B)(4) AND MONITORING OF (B)(4) DURING THE MFG PROCESSES ARE CURRENTLY IN PLACE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) REC'D A REPORT THAT DURING BYPASS, BLOOD WAS SEEN COMING FROM THE BOTTOM OF THE OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT WITHIN THREE MINS W/O ISSUE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1011180031

    Patients

    Seq Age Sex Outcome Treatment
    1