BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HD SYS. CDX W/BIBAG BLUE STAR

    MDR report key: 16564075 · Received March 17, 2023

    Report

    Report Number
    0002937457-2023-00402
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    March 13, 2023
    Report Date
    March 28, 2023
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861102099
    PMA / PMN Number
    K173972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE BLOOD PUMP ROTOR WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE RETURNED ROTOR SHOWED ONE OF THE REAR GUIDE SHEAVE (POLYMER SLEEVE) DEFORMED AND LOOSE. THE SLEEVE CAN BE REMOVED FROM THE GUIDE PIN. THE GUIDE PIN APPEARS TO HAVE WEAR MARKINGS. THERE ARE NO DISCREPANCIES WITH THE OTHER THREE GUIDE PIN AND SLEEVES. INSTALL THE RETURNED ROTOR ONTO THE BLOOD PUMP MODULE OF A TEST MACHINE FOR TESTING. A PATIENT TEST WAS PERFORMED WITH FRESENIUS¿S COMBISET BLOODLINE AND WATER IN DIALYSIS (BLOOD PUMP RATE SET AT 450 ML/MIN) FOR 2 HOURS. THE ROTOR DID NOT DAMAGE THE BLOODLINE AND THERE WERE NO FLUID LEAKS OR ALARMS DURING TESTING. THE DEFECTIVE REAR SLEEVE DID NOT DISLODGE FROM THE PIN. THERE WAS NO FURTHER DAMAGE OCCURRED TO THE ROTOR DURING TESTING. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE REPORTED ISSUE WAS CONFIRMED.

    Description of Event or Problem · 0

    A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE HAD A LOOSE BLOOD PUMP ROTOR TUBING GUIDE. UPON FOLLOW UP, THE CUSTOMER SAID THAT THE MACHINE WAS RETURNED TO SERVICE AFTER THEY REPLACED THE ROTOR. THIS OCCURRED DURING TREATMENT. THE PATIENT DID LOSE BLOOD AS A RESULT. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. THE BMT DID NOT HAVE ANY INFORMATION ON THE PATIENT OR THE NAME OF WHO TO CONTACT FOR PATIENT INFORMATION.

    Description of Event or Problem · 0

    A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE HAD A LOOSE BLOOD PUMP ROTOR TUBING GUIDE. UPON FOLLOW UP, THE CUSTOMER SAID THAT THE MACHINE WAS RETURNED TO SERVICE AFTER THEY REPLACED THE ROTOR. THIS OCCURRED DURING TREATMENT. THE PATIENT DID LOSE BLOOD AS A RESULT. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. THE BMT DID NOT HAVE ANY INFORMATION ON THE PATIENT OR THE NAME OF WHO TO CONTACT FOR PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559056 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 191126 00840861102099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown