BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMATE PACK FAIRFIELD MEDICAL CENTER, LANCASTER OH

    MDR report key: 5200786 · Received March 31, 2004

    Report

    Report Number
    1718850-2004-00003
    Event Type
    Malfunction
    Date Received
    March 31, 2004
    Date of Event
    March 23, 2004
    Report Date
    March 24, 2004
    Manufacturer
    COBE CARDIOVASCULAR, INC
    Product Code
    DWE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBING SECTION WAS CUT AT THE POINT OF THE SPLIT BY THE FACILITY AND RETURNED TO COBE FOR EVALUATION. VISUAL EXAMINATION OF THE TUBING SHOWED A SMALL (1/4") SECTION OF THE TUBING HAD BEEN RUBBED DOWN FROM THE TUBING ROLLER GUIDES. AT ONE END OF THIS YEAR, THERE WAS A HOLE THAT APPEARS TO HAVE BEEN CAUSED BY THE ROLLER GUIDE PIERCING IT. THIS VISUAL EXAMINATION SUPPORTS THE DESCRIPTION PROVIDED BY THE USER FACILITY. THAT FACILITY REPORTED THAT THE RUPTURE WAS CAUSED BY MIGRATION OF THE TUBING IN THE ARTERIAL HEAD RACEWAY OF THEIR HEART-LUNG PERFUSION EQUIPMENT. THEY ALSO WERE ABLE TO DUPLICATE THE EVENT ON ANOTHER HEART LUNG MACHINE. NEW TUBING GUIDES WERE ADDED TO THE INFLOW CLAMP OR ARTERIAL HEAD PUMP TO PREVENT FUTURE MIGRATION OF TUBING. VISUAL INSPECTION WAS ADDED TO PRE-BY-PASS CHECKLIST AND SCAN DURING ANY APB RUN. IN CONCLUSION, THE EVENT WAS CAUSED BY FAILURE TO COMPLETELY SECURE THE TUBING IN THE EQUIPMENT NOT BY A DEFECT IN THE TUBING.

    Description of Event or Problem · 1

    PRIOR TO CPB AND DURING THE PUMP RUN, THERE WAS NO INDICATION OF ARTERIAL HEAD BOOT EXCESS IN THE RACEWAY. NEAR THE END OF THE PROCEDURE PRIOR TO TERMINATION OF BYPASS, THE PUMP HEADER TUBING SPLIT RESULTING IN LOSS OF APPROXIMATELY 500 CC OF BLOOD. CPB WAS TERMINATED AND PATIENT WAS FILLED WITH ADEQUATE BLOOD VOLUME AND VENTILATOR WAS STARTED. NO APPARENT INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMATE PACK FAIRFIELD MEDICAL CENTER, LANCASTER OH CUSTOM PERFUSION PACK DWE COBE CARDIOVASCULAR, INC NA 0332200042

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other