BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HD SYS. W/O CDX W/BIBAG BLUE STAR

    MDR report key: 16109723 · Received January 5, 2023

    Report

    Report Number
    0002937457-2023-00023
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 5, 2023
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861102112
    PMA / PMN Number
    K173972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE BLOOD PUMP ROTOR WAS RETURNED WITH A CRACKED ROTOR COVER. ONE OF THE REAR GUIDE SHEAVES (POLYMER SLEEVE) WAS DEFORMED AND LOOSE. THE SLEEVE EASILY SLID OUT FROM THE PIN. THERE WERE NO DISCREPANCIES WITH THE OTHER THREE GUIDE PINS AND SLEEVES. THE SLEEVE WAS INSERTED BACK ONTO THE GUIDE PIN AND THE ROTOR WAS INSTALLED ONTO THE BLOOD PUMP MODULE OF A TEST MACHINE. A PATIENT TEST WAS PERFORMED WITH FRESENIUS¿S COMBI SET BLOODLINE SET UP USING WATER. THE RETURNED ROTOR DID NOT PUNCTURE THE BLOODLINE AND NO FLUID LEAK OCCURRED DURING TESTING. HOWEVER, THE DEFECTIVE SLEEVE BECAME LOOSE, CONTACTING THE RIM OF THE ROTOR HOUSING, CREATING A ¿CLICKING¿ NOISE. THE SLEEVE DID NOT FULLY DISLODGE FROM THE GUIDE PIN. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF TESTING, THE REPORTED COMPLAINT HAS BEEN CONFIRMED. THE EVALUATION IDENTIFIED A MECHANICAL FAILURE ON THE TUBING GUIDE PIN, WHICH CAUSED THE SLEEVE TO BE LOOSE. THE SLEEVE WAS CONTACTING THE HOUSING, CAUSING CLICKING NOISES AND DEFORMING THE SLEEVE.

    Description of Event or Problem · 0

    A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SUPPORT THAT THE BLOOD PUMP ROTOR ON A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE DAMAGED THE BLOODLINE WHICH RESULTED IN PATIENT BLOOD LOSS. WITHIN THE FIRST MINUTE OF THE PATIENT¿S HD TREATMENT, BLOOD WAS OBSERVED DRIPPING FROM THE BLOOD PUMP MODULE. THERE WERE NO REPORTED MACHINE ALARMS. THE PATIENT WAS UTILIZING A NIPRO DIALYZER WITH NIPRO BLOODLINES. THERE WAS NO LEAKING NOTED DURING THE PRIMING PHASE. ONCE THE LEAK WAS NOTICED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 200 ML. UPON INSPECTING THE BLOODLINES, A PUNCTURE MARK (OR TEAR) WAS IDENTIFIED ON THE SEGMENT OF TUBING THAT SITS IN THE BLOOD PUMP MODULE. REPORTEDLY, THE BLOODLINE LOOKED LIKE IT WAS PINCHED INSIDE THE BLOOD PUMP ROTOR, EFFECTIVELY TEARING THE TUBING. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE MACHINE WAS REMOVED FROM SERVICE FOR EVALUATION AND THE BIOMED REPLACED THE BLOOD PUMP ROTOR. THE BIOMED CONFIRMED THIS RESOLVED THE ISSUE. THE BIOMED STATED THE MACHINE'S HOUR METER READING WAS 4,601 HOURS AT THE TIME OF THE EVENT. THE BLOOD PUMP ROTOR THAT WAS REMOVED FROM THE MACHINE WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508419 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 191130 00840861102112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown