BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 20095253 · Received August 29, 2024

    Report

    Report Number
    2523676-2024-00797
    Event Type
    Death
    Date Received
    August 29, 2024
    Date of Event
    March 30, 2024
    Report Date
    November 14, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    PMA / PMN Number
    K080807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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). A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. FIVE RETAINS FROM THE REPORTED LOT NUMBER WERE TESTED AND PASSED. NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. 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.

    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. NOTE: ORIGINAL REPORT WAS SENT UNDER 2521402-2024-00086. AFTER RECEIVING THE CORRECT LOT NUMBER FROM THE CUSTOMER VIA EMAIL ON 08AUG2024, IT WAS DETERMINED THAT THE INCORRECT MANUFACTURING REPORT # WAS USED. THIS REPORT CREATED BASED ON THE NEW INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPROTS THAT ON (B)(6), A PATIENT WAS HOOKED UP TO THE DIALOG FOR DIALYSIS AND 15 MINUTES INTO TREATMENT THE PATIENTS VENOUS BLOODLINE CAME DETACHED FROM HIS CVC. THE PATIENT EXSANGUINATED AND CODED. THE PATIENT WAS BRIEFLY RESCUSUTATED AND TRANSPORTED TO THE HOSPITAL, WHICH WAS ABOUT 1/4 MILE AWAY FROM THE DIALYSIS CENTER, WHERE HE CODED A SECOND TIME AND EXPIRED. PATIENT WAS 70 YEAR OLD MALE. HE WAS NOT NEW TO DIALYSIS, BUT WAS ALSO NOT A LONG-TERM PATIENT. HIS ACCESS WAS A CVC THE FOLLOWING EMAIL RESPONSES WERE RECEIVED BY THE CUSTOMER ON 07AUGUST2024: 1. HOW WAS THE INCIDENT DISCOVERED? DISCOVERED BY PCT WORKING WITH PATIENT. 2. WHAT HOSPITAL WAS THE PATIENT TRANSPORTED TO? (B)(6) HOSPITAL. 3. WHAT MEDICAL INTERVENTIONS WERE NEEDED AT THE DIALYSIS CENTER AND WHAT WAS NEEDED LATER AT THE HOSPITAL? CPR< CLAMPING BLOOD LINES / INTUBATION AND BLOOD ADMINISTRATION. 4. DID THE MACHINE ALARM AT THE TIME OF THE EVENT? YES - LOGS SHOWED A VENOUS ALARM WAS SILENCED AND MANUAL BLOOD PRESSURE WAS STARTED. 5. CAN ADDITIONAL INFORMATION BE PROVIDED ON THE BLOODLINE DETACHMENT. SPECIFICALLY, WHERE ON THE BLOODLINE DID THE DETACHMENT OCCUR? CONNECTION BETWEEN CVC VENOUS PORT AND BLOODLINES NOT TIGHT. 6. WAS THERE ANY VISUAL DAMAGE OR ISSUE IDENTIFIED WITH THE BLOODLINE. NO. 7. IS THE BLOODLINE BATCH AVAILABLE? IF SO, CAN IT BE PROVIDED? YES - 00619221B4. 8. WAS AN AUTOPSY PERFORMED? IF SO, CAN IT BE PROVIDED? YES, DO NOT HAVE A COPY. 9. WAS THERE AN OFFICIAL CAUSE OF DEATH? YES, DO NOT HAVE ON FILE. THE FOLLWING EMAIL RESPONSE WAS RECEIVED BY THE CUSTOMER ON 08AUGUST2024: YES, THE LETTER B WAS MISINTERPRETED. 0061922184 IS THE PROPER NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356498 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD WITH AND WITHOUT A FJK B. BRAUN MEDICAL INC. 0061922184

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death