BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 18837633 · Received March 5, 2024

    Report

    Report Number
    2521402-2024-00034
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 19, 2024
    Report Date
    November 20, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    UDI-DI
    04046964367762
    PMA / PMN Number
    K080807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL 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). EVENT 4 A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. THREE (3) USED SAMPLES WITHOUT ORIGINAL PACKAGING AND FIVE (5) PHOTOGRAPHS WERE PROVIDED FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED ON THE PHOTOGRAPHS AND THE SAMPLES RETURNED; IT WAS NOTED THAT A SMALL CUT WAS OBSERVED IN THE ARTERIAL LINE PUMP SEGMENT DEPICTED IN SEVERAL OF THE PHOTOGRAPHS. BASED ON THE INVESTIGATION FINDINGS, THE PRODUCTS WERE NOT WITHIN SPECIFICATION; THEREFORE, THE REPORTED DEFECT WAS CONFIRMED. WHILE A DEFECT WAS CONFIRMED, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. 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

    EVENT 4. AS REPORTED BY THE USER FACILITY: PER CUSTOMER EMAIL TO CARDINAL: YESTERDAY OUR DCI LAFAYETTE CLINIC EXPERIENCED MULTIPLE BLOODLINES WITH HOLES IN THEM ON THE BLOOD PUMP PORTION OF THE LINE. THEY HAVE SAVED 2 OF THE LINES THAT WERE USED IF YOU NEED THEM. UPON INSPECTION OF OTHER LINES IN THIS SAME LOT THEY FOUND MANY MORE. PER EMAIL ATTACHMENT: AIR NOTICED IN LINE WITH BLOOD LEAKING AROUND BLOOD PUMP. PATIENTS RINSED BACK AS MUCH AS SAFELY POSSIBLE. AFTER REMOVING BLOOD LINES A TEAR IN THE LINE WAS VISIBLE. THIS HAPPENED AGAIN WITH ANOTHER PATIENT. AFTER THE SECOND INCIDENT ALL LINES WITH THE LOT # 230118 WAS PULLED FROM FLOOR. UPONE EXAMINING SOME OF THE PULLED LINES 6 OTHER LINES WERE NOTICED TO HAVE 'TEARS' IN THE BLOOD PUMP PORTION OF LINE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519755 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH A FJK B. BRAUN MEDICAL INC. A2301118 04046964367762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown