BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HD SYS. CDX W/BIBAG BLUE STAR

    MDR report key: 16522979 · Received March 10, 2023

    Report

    Report Number
    0002937457-2023-00361
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 30, 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

    PLANT INVESTIGATION: THE BLOOD PUMP ROTOR DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE RETURNED ROTOR SHOWED ONE OF THE REAR GUIDE SHEAVE (POLYMER SLEEVE) LOOSE AND DEFORMED. THE SLEEVE WAS EASILY BE REMOVED FROM THE GUIDE PIN (BEARING JOURNAL) AND THE GUIDE PIN APPEARED TO HAVE WEAR MARKS AND DEBRIS. THE OTHER REAR PIN HAD DEBRIS FROM THE SLEEVE. THERE WERE NO DISCREPANCIES WITH THE TWO FRONT PINS AND SLEEVES. INSTALLED 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. ENCOUNTERED CLICKING NOISE DURING TESTING DUE TO SLEEVE RUBBING AGAINST ROTOR HOUSING. THE ROTOR DID NOT DAMAGE THE BLOODLINE AND THERE WERE NO FLUID LEAKS AND/OR ALARMS DURING TESTING. THERE WAS NO FURTHER DAMAGE 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. UPON COMPLETION OF THE EVALUATION, THE REPORTED FLUID LEAK EVENT COULD NOT BE REPLICATED. THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT THE BLOOD PUMP TUBING WAS CUT BY THE BLOOD PUMP ROTOR. UPON FOLLOW-UP, THE BMT STATED ABOUT HALFWAY THROUGH THE PATIENT'S TREATMENT THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, SLIT OPEN THE BLOOD PUMP TUBING AND CAUSED A BLOOD LEAK TO OCCUR. THE BMT STATED THE ROTOR SLEEVES (AROUND THE PINS) WERE LOOSE AND SLIPPING OFF AND CAUSING PINCHING AND TEARING ON THE BLOOD PUMP TUBING. THE BMT STATED THEY WERE ABLE TO MANUALLY PULL THE SLEEVES OFF OF THE ROTOR SLEEVES. THE BMT HAD ALREADY REPLACED THE BLOOD PUMP ROTOR PRIOR TO THE CALL AND THE MACHINE WAS PLACED BACK IN SERVICE. THE ROTOR WAS NOT THE ORIGINAL TO THE MACHINE (BLOOD PUMP HAD PREVIOUSLY BEEN REPLACED ON THIS DEVICE). THE BMT ALSO STATED THAT A FRESENIUS DIALYZER AND FRESENIUS BLOODLINES WERE USED FOR TREATMENT AND CONFIRMED THAT THERE WERE NO DEFECTS OR DAMAGE SEEN ON THE MACHINE, DIALYZER OR BLOODLINE PRIOR TO THE EVENT. PER BMT TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE BMT STATED THE ESTIMATED BLOOD LOSS WAS 300ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE BMT CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE BMT STATED THE COMPONENT WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

    Description of Event or Problem · 0

    A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT THE BLOOD PUMP TUBING WAS CUT BY THE BLOOD PUMP ROTOR. UPON FOLLOW-UP, THE BMT STATED ABOUT HALFWAY THROUGH THE PATIENT'S TREATMENT THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008T MACHINE, SLIT OPEN THE BLOOD PUMP TUBING AND CAUSED A BLOOD LEAK TO OCCUR. THE BMT STATED THE ROTOR SLEEVES (AROUND THE PINS) WERE LOOSE AND SLIPPING OFF AND CAUSING PINCHING AND TEARING ON THE BLOOD PUMP TUBING. THE BMT STATED THEY WERE ABLE TO MANUALLY PULL THE SLEEVES OFF OF THE ROTOR SLEEVES. THE BMT HAD ALREADY REPLACED THE BLOOD PUMP ROTOR PRIOR TO THE CALL AND THE MACHINE WAS PLACED BACK IN SERVICE. THE ROTOR WAS NOT THE ORIGINAL TO THE MACHINE (BLOOD PUMP HAD PREVIOUSLY BEEN REPLACED ON THIS DEVICE). THE BMT ALSO STATED THAT A FRESENIUS DIALYZER AND FRESENIUS BLOODLINES WERE USED FOR TREATMENT AND CONFIRMED THAT THERE WERE NO DEFECTS OR DAMAGE SEEN ON THE MACHINE, DIALYZER OR BLOODLINE PRIOR TO THE EVENT. PER BMT TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE BMT STATED THE ESTIMATED BLOOD LOSS WAS 300ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE BMT CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE BMT STATED THE COMPONENT WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054195 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 FRESENIUS BLOODLINES| FRESENIUS BLOODLINES| FRESENIUS DIALYZER| FRESENIUS DIALYZER