BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    MDR report key: 6636177 · Received June 13, 2017

    Report

    Report Number
    1820334-2017-01405
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    May 16, 2017
    Report Date
    December 1, 2017
    Manufacturer
    COOK INC
    Product Code
    MPB
    UDI-DI
    00827002350830
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: COMMON DEVICE NAME: CATHETER, HEMODIALYSIS, NON-IMPLANTED. PRODUCT CODE: MPB. 510(K): K161504. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND VISUAL INSPECTION/FUNCTIONAL DATA OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE CATHETER WAS RETURNED WITH BIOMATTER PRESENT ON THE DISTAL END OF THE CATHETER. THE MANIFOLD ASSEMBLY WAS INTACT WITH THE ARTERIAL AND VENOUS PORTS AND CLAMPS INTACT. THE VENOUS EXTENSION TUBING WAS KINKED BECAUSE IT HAD BEEN CLAMPED PRIOR TO SHIPPING. THROUGH THE VENOUS SIDE, FLUID WAS INTRODUCED INTO THE CATHETER. FLUID WENT THROUGH THE CATHETER WITH NO LEAKS. THE CLAMP WAS THEN ACTIVATED ON THE VENOUS SIDE AND FLUID WAS INTRODUCED WITH A SYRINGE USING SIGNIFICANT FORCE AND NO FLUID WENT THROUGH. THROUGH THE ARTERIAL SIDE, FLUID WAS INTRODUCED INTO THE CATHETER. FLUID WENT THROUGH THE CATHETER WITH NO LEAKS. THE CLAMP WAS THEN ACTIVATED ON THE ARTERIAL SIDE AND FLUID WAS INTRODUCED WITH A SYRINGE AND WENT THROUGH THE CATHETER. THIS CONFIRMS THE CUSTOMER'S COMPLAINT THAT BLOOD KEPT FLOWING THROUGH THE CATHETER AFTER CLAMPING IT. THERE WERE NO RELATED NONCONFORMANCES FOR THE FINAL PRODUCT OR ANY OF THE MANIFOLD SUBASSEMBLIES USED IN THE FINAL LOT. TO DATE, THIS IS THE ONLY KNOWN COMPLAINT ASSOCIATED WITH THIS LOT NUMBER. NO VISUAL DAMAGE TO EITHER THE PINCH CLAMP OR EXTENSION TUBING WAS OBSERVED IN INVESTIGATION OF THE RETURNED PRODUCT BUT THE FAILURE MODE WAS DUPLICATED. FOR THIS REASON, THE ROOT CAUSE IS UNKNOWN. THIS IS THE ONLY COMPLAINT ON THIS PRODUCT FAMILY FOR LEAKING CLAMP IN THE LAST THREE YEARS AND BASED ON THE ASSOCIATED SEVERITY OF THE FAILURE, FURTHER RISK REDUCTION IS NOT REQUIRED AT THIS TIME. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE COOK TURBO-FLO HD HEMODIALYSIS CATHETER WAS IN USE FOR TREATMENT. CUSTOMER STATES "DESPITE THE FORCEPS BEING CLOSED THE BLOOD KEPT FLOWING." THE CUSTOMER REPORTS THAT ANOTHER CATHETER WAS NEEDED. NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417870 COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET MPB COOK INC N/A 00827002350830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention