BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS COMBI SET TRUE FLOW SERIES BLOOD TUBING -8

    MDR report key: 2964174 · Received February 8, 2013

    Report

    Report Number
    MW5028979
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE OF NORTH AMERICA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER: FRESENIUS MEDICAL CARE (B)(4) PRODUCT NAME: COMBI SET TRUE FLOW SERIES BLOOD TUBING -8MM PUMP SEGMENT- CATALOG #: 03-2722-9, LOT #: 12PRO1896, EXP: 11/2015. WE RECEIVED 18 CASES ON (B)(6) 2013. WHEN I PULLED THE PRODUCT FROM USE, WE HAD 6 CASES AND 5 INDIVIDUAL PACKAGES REMAINING. EACH CASE CONTAINS 24 PACKAGES, SO WE USED 283 PACKAGES OF THE TOTAL 432 WE HAD IN STOCK. OF THOSE 283 PACKAGES WE HAVE HAD (B)(6) OCCURRENCES OF ABNORMAL ARTERIAL - AND OCCASIONALLY VENOUS - PRESSURE READINGS WHILE A PATIENT WAS ON TREATMENT. THE DATES OF THE EVENTS WERE: (B)(6) -TWO EVENTS-, (B)(6) -TWO EVENTS- AND (B)(6) -ONE EVENT-. WHEN I INVESTIGATED THE FIVE EVENTS, I FOUND THAT ALL OF THE PATIENTS USED THE SAME TUBING FROM THE SAME LOT NUMBER. I ALSO FOUND THAT EVERY PATIENT WAS ALSO USING THE SAME DIALYZER FROM THE SAME LOT NUMBER -DIFFERENT PRODUCT, DIFFERENT MANUFACTURER-. FROM THIS INFORMATION I WAS NOT ABLE TO DETERMINE THE SPECIFIC CAUSE OF THE ABNORMALITIES. VISUAL INSPECTION OF BOTH PRODUCTS -FROM THREE TUBING AND DIALYZER SETS USED ON AFFECTED PATIENTS- YIELDED NO OBVIOUS DEFECTS. I DID NOT HAVE ENOUGH OF AN ALTERNATIVE LOT NUMBER OF DIALYZERS ON HAND, SO I MADE THE DECISION TO PULL THE TUBING SO THAT WE COULD CONTINUE TO PROVIDE TREATMENTS TO OUR PATIENTS WHILE SIMULTANEOUSLY ELIMINATING ONE OF THE POTENTIAL CAUSES OF THE ABNORMAL PRESSURE READINGS. THE AFOREMENTIONED LOT NUMBER WAS PULLED FROM USE ON (B)(6) AT APPROXIMATELY 12:15 PM, IMMEDIATELY FOLLOWING THE FOURTH OCCURRENCE. SINCE THAT TIME, THERE HAVE BEEN NO FURTHER REPORTS OF ANY ABNORMAL PRESSURE READINGS. GIVEN THAT DURING THE FIRST WEEK OF USING THIS TUBING FROM (B)(6) THERE WERE NO REPORTS OF ABNORMAL PRESSURES, THE ABSENCE OF ANY REPORTS FROM (B)(6) TO PRESENT DAY IS ONLY SUGGESTIVE THAT THE TUBING MAY BE RESPONSIBLE FOR THE NOTED ABNORMALITIES. I CANNOT SAY DEFINITIVELY THAT THIS IS THE ROOT CAUSE. IT IS POSSIBLE THAT ONLY A SMALL SUBSET OF THIS TUBING HAD ISSUES. IT MAY ALSO BE POSSIBLE THAT A SMALL SUBSET OF THE SPECIFIC LOT NUMBER OF DIALYZER THAT ALL THESE PATIENTS WERE ON WAS TO BLAME. I CANNOT SAY WITH ANY CERTAINTY EITHER WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54919 FRESENIUS COMBI SET TRUE FLOW SERIES BLOOD TUBING -8 DIALYSIS TUBING FJK FRESENIUS MEDICAL CARE OF NORTH AMERICA 12PRO1896

    Patients

    Seq Age Sex Outcome Treatment
    1