BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    MDR report key: 7348927 · Received March 19, 2018

    Report

    Report Number
    1820334-2018-00716
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    February 22, 2018
    Report Date
    June 13, 2018
    Manufacturer
    COOK INC
    Product Code
    MPB
    UDI-DI
    00827002350830
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS RELATED TO THIS FAILURE FOR THIS LOT NUMBER. THE IFU STATES PREPARE THE CATHETER FOR INSERTION BY FLUSHING EACH OF THE LUMENS WITH NORMAL SALINE, AND CLAMP THE PROXIMAL EXTENSION." IT ALSO NOTES THAT FLOW RATES FOR BOTH THE ARTERIAL AND VENOUS LUMENS RANGE FROM 100 ML/MIN TO 400 ML/MIN. HOWEVER, THE MAXIMUM FORWARD AND REVERSE FLOW PRESSURES VARY WITH FLOW RATES. THE IFU ALSO STATES UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A TWO DIMENSIONAL IMAGE WAS PROVIDED TO MARK THE LOCATION OF THE LONGITUDINAL FISSURE (CRACK) ALONG THE RED ARTERIAL LUMEN. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: CATHETER, HEMODIALYSIS, NON-IMPLANTED. PROCODE: MPB. (B)(4) THE 510K #: K161504. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT, UPON STARTING THE PATIENT'S DIALYSIS THERAPY IN WHICH A COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET WAS USED IN THE FEMORAL VEIN, SMALL BUBBLES WERE SEEN IN THE TUBING OF THE DEVICE. THE LUER LOCK WAS CHECKED, AND EVERYTHING APPEARED TO BE NORMAL. HOWEVER, SMALL BUBBLES WERE STILL OBSERVED ALONG THE ARTERIAL STRETCH. THE CUSTOMER THEN NOTICED THAT THE CONNECTION OF THE ARTERIAL STRETCH IS SLIGHTLY BROKEN, AND THAT A BLOOD LEAK WAS STAINING THE GAUZE THAT WAS UNDERNEATH IT. THE CATHETER ULTIMATELY HAD TO BE CHANGED OUT. THE PRODUCT IS UNAVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193944 COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET MPB COOK INC N/A 00827002350830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention