BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 13683582 · Received March 7, 2022

    Report

    Report Number
    2521402-2022-00015
    Event Type
    Injury
    Date Received
    March 7, 2022
    Date of Event
    February 10, 2022
    Report Date
    April 29, 2022
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    FJK
    UDI-DI
    04046955348909
    PMA / PMN Number
    K080807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE SAMPLE AND PHOTO WERE PROVIDED FOR EVALUATION. SAMPLE WAS DECONTAMINATED UPON ARRIVAL AND THEN FUNCTIONALLY LEAK TESTED BY ATTACHING AIRLINE AT 10 PSI FOR 10 SECONDS AND HELD UNDERWATER, IT WAS NOTED THAT THERE WAS A LARGE CUT ALONG WITH #17 PUMP SEGMENT TUBING. LARGE CUTS FOUND IN TUBING WOULD HAVE ALSO CAUSED AIR TO BE PRESENT IN THE SET DURING USE. PHOTOGRAPH RETURNED WAS ALSO VISUALLY EVALUATED AND IT WAS NOTED THAT IT IS DIFFICULT TO DETERMINE THE LOCATION OF LEAKAGE WITH SET ATTACHED TO THE PUMP. BASED ON THE RESULTS OF THE VISUAL AND FUNCTIONAL EVALUATION OF THE SAMPLE AND PHOTOGRAPH RETURNED, THE REPORTED LEAKAGE DEFECT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR SL-2000M2095L LOT A2100630 WAS PERFORMED AND INDICATED THAT THERE WERE NO QUALITY ISSUES DURING THE MANUFACTURING PROCESS OF THIS LOT RELATED TO THE REPORTED ISSUE. A SEARCH OF THE COMPLAINT DATABASE FOR THIS BLOOD TUBING SET LOT NUMBER SHOWS NO ADDITIONAL COMPLAINTS OF A SIMILAR NATURE AS OF COMPLAINT CLOSURE, INDICATING THIS IS AN ISOLATED OCCURRENCE. POTENTIAL ROOT CAUSE IS LACK OF SOLVENT ON THE SET. INCIDENTS OF THIS NATURE ARE ATTRIBUTED TO OPERATOR OVERSIGHT DURING THE ASSEMBLY OF THE PRODUCT. AS A RESULT OF THIS OCCURRENCE A QUALITY ALERT WAS GENERATED TO NOTIFY AND RETAIN ALL PERSONNEL ON THE SOLVENT APPLICATION TECHNIQUE IN ORDER TO PREVENT REOCCURRENCE. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: A LEAK OCCURRED ON THE ARTERIAL PORTION OF THE BLOODLINE ADJACENT TO THE SALINE LINE. PATIENT REPORTED DYSPNEA, CHEST PAIN AND DIAPHORESIS. VITAL SIGNS WERE STABLE. PATIENT WAS PLACED ON OXYGEN. THE RAPID RESPONSE WAS CALLED AND NITROGLYCERIN WAS GIVEN FOR THE CHEST PAIN. PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893524 HEMODIALYSIS BLOODLINES BLOOD TUBING SETS FJK B. BRAUN MEDICAL INC SL-2000M2095L A2100630 04046955348909

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other