BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKAY DEE HSOP OGDEN UT 1

    MDR report key: 1210072 · Received July 31, 2008

    Report

    Report Number
    1718850-2008-00018
    Event Type
    Malfunction
    Date Received
    July 31, 2008
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ONE HEART LUNG PACK WAS RETURNED TO SORIN GROUP USA, INC. FOR EVAL OF DEBRIS. A VISUAL INSPECTION FOUND A SOLVENT APPLICATOR TIP IN THE REVOLUTION PUMP HEAD. NO OTHER DEBRIS WAS FOUND IN THE REMAINING CIRCUIT. THIS SOLVENT APPLICATOR TIP IS USED IN MFG. IT APPEARS THAT THE APPLICATOR TIP WAS INADVERTENTLY LEFT IN THE PRODUCT DURING ASSEMBLY. THE PERSONNEL RESPONSIBLE FOR THIS PART OF THE ASSEMBLY WERE IDENTIFIED BY THE LOT NUMBER REPORTED. THE APPROPRIATE MFG DOCUMENTS FOR THIS ASSEMBLY WERE REVIEWED AND REMEDIAL TRAINING WAS PERFORMED. NO FURTHER ACTION WAS DEEMED NECESSARY. THE HEART/LUNG PERFUSION PACK INSTRUCTIONS FOR USE STATE THAT THE SORIN GROUP USA, INC. PRE-BYPASS FILTER IS INDICATED FOR USE DURING PRIMING OF THE CIRCUIT TO REMOVE CONTAMINATES LARGER THAN 5 MICRONS. IN ADDITION, IT IS RECOMMENDED TO USE SAFETY DEVICES SUCH AS AN ARTERIAL FILTER TO AID IN THE DETECTION OF PARTICULATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCKAY DEE HSOP OGDEN UT 1 CUSTOM PERFUSION PACK DTZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1