BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYGON S-65-HL

    MDR report key: 760837 · Received September 13, 2006

    Report

    Report Number
    1519258-2006-00001
    Event Type
    Injury
    Date Received
    September 13, 2006
    Date of Event
    June 16, 2006
    Report Date
    September 8, 2006
    Manufacturer
    SAINT-GOBAIN PERFORMANCE PLASTICS
    Product Code
    DWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TYGON S-65-HL IS SOLD ONLY TO MEDICAL DEVICE MANUFACTURERS WHO INCORPORATE THE TUBING INTO THEIR FINISHED DEVICE OR ECMO PACK. CO DOES NOT HOLD THE 510K ON THIS CLASS II DEVICE AND RECOMMENDS EACH CUSTOMER CONDUCT TESTING ON THE PRODUCT AS PART OF THE COMPLETED DEVICE. WE HAVE TRIED AND WILL CONTINUE TO TRY TO OBTAIN THE NECESSARY LOT NUMBERS AND OEM INFORMATION. THIS INFORMATION WILL ENABLE CO TO CONDUCT A THOROUGH REVIEW OF THE PRODUCT AND PROCESS TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED. ATTACHED IS A LETTER SENT TO REPORTER OBTAIN SPECIFICS ON THE PRODUCT AND INCIDENT. THIS WAS ISSUED AFTER SEVERAL PHONE CONVERSATIONS. CONTINUED EFFORTS TO RESOLVE THIS AS QUICKLY AS POSSIBLE ARE IN PROGRESS.

    Description of Event or Problem · 1

    (DESCRIPTION PREVIOUSLY REPORTED). TUBING THAT WAS THREADED AROUND THE ROLLER-HEAD OF AN EXTRACORPOREAL MEMBRANE OXYGENATION -ECMO- MACHINE CRACKED. THE TUBING WAS REMOVED FROM THE PUMP AND REPLACED WITH NEW TUBING. PATIENT WAS REMOVED FROM ECMO SUPPORT DURING THIS REPAIR. PATIENT REQUIRED ONE DOSE OF EPINEPHRINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYGON S-65-HL TUBING, PUMP TUBING DWE SAINT-GOBAIN PERFORMANCE PLASTICS S-65-HL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| S