BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16335084 · Received February 9, 2023

    Report

    Report Number
    0002937457-2023-00191
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 9, 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

    CORRECTION: D8 ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: A BLOOD PUMP ROTOR WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN INSPECTION ON THE RETURNED ROTOR SHOWED ONE OF THE REAR GUIDE SHEAVES (POLYMER SLEEVE) WAS LOOSE AND DAMAGED AND THE OTHER REAR PIN HAD A MISSING SLEEVE. THERE ARE NO DISCREPANCIES WITH THE TWO FRONT GUIDE PINS AND SLEEVES. THE RETURNED ROTOR WAS INSTALLED ONTO THE BLOOD PUMP MODULE OF A TEST MACHINE FOR TESTING. A PATIENT TEST WAS PERFORMED WITH FRESENIUS¿S COMBISET BLOODLINE SET AND WATER IN DIALYSIS MODE. THE RETURNED ROTOR DID NOT DAMAGE THE BLOODLINE AND THERE WERE NO FLUID LEAKS, ALARMS, OR UNUSUAL CLICKING NOISES DURING TESTING. NONE OF THE GUIDE SLEEVES DID NOT DISLODGE FROM THE GUIDE PINS THROUGHOUT THE TEST. A PRODUCT HISTORY REVIEW WAS COMPLETED DURING THE INVESTIGATION 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. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO CONFIRM THE REPORTED FAILURE MODE AS THE REPORTED ISSUE COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE BLOOD PUMP ROTOR TUBING GUIDE ON A 2008T MACHINE CAME LOOSE AND CUT THE TUBING OF THE (NON-FRESENIUS) BLOODLINES DURING PATIENT TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP FROM A USER FACILITY REGISTERED NURSE (RN). THE RN STATED THAT THE PATIENT WAS APPROXIMATELY 20 MINUTES INTO HEMODIALYSIS (HD) TREATMENT ON THE 2008T MACHINE (SETUP WITH NON-FRESENIUS SUPPLIES) WHEN BLOOD WAS OBSERVED LEAKING FROM THE FRONT OF THE MACHINE. THE RN STATED THAT THE MACHINE DID NOT ALARM TO ALERT THE STAFF TO THE ISSUE. THERE WAS NO ISSUE IDENTIFIED WITH THE BLOODLINES PRIOR TO THE OCCURRENCE OF THIS EVENT. TREATMENT WAS PAUSED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) COULD NOT BE PROVIDED. THE RN CONFIRMED THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON A NEW MACHINE WITH NEW SUPPLIES. THE RN STATED UPON CLOSER INSPECTION OF THE BLOODLINES A SMALL SECTION OF THE TUBING APPEARED TO BE PINCHED RESULTING IN A CRACK APPROXIMATELY 3 MM LONG. THE RN ALSO NOTED THAT THE MACHINE WAS MAKING A CLICKING NOISE PRIOR TO THE EVENT. THE BIOMED STATED DURING FOLLOW-UP THAT THE BLOOD PUMP ROTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Description of Event or Problem · 0

    A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE BLOOD PUMP ROTOR TUBING GUIDE ON A 2008T MACHINE CAME LOOSE AND CUT THE TUBING OF THE (NON-FRESENIUS) BLOODLINES DURING PATIENT TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP FROM A USER FACILITY REGISTERED NURSE (RN). THE RN STATED THAT THE PATIENT WAS APPROXIMATELY 20 MINUTES INTO HEMODIALYSIS (HD) TREATMENT ON THE 2008T MACHINE (SETUP WITH NON-FRESENIUS SUPPLIES) WHEN BLOOD WAS OBSERVED LEAKING FROM THE FRONT OF THE MACHINE. THE RN STATED THAT THE MACHINE DID NOT ALARM TO ALERT THE STAFF TO THE ISSUE. THERE WAS NO ISSUE IDENTIFIED WITH THE BLOODLINES PRIOR TO THE OCCURRENCE OF THIS EVENT. TREATMENT WAS PAUSED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) COULD NOT BE PROVIDED. THE RN CONFIRMED THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON A NEW MACHINE WITH NEW SUPPLIES. THE RN STATED UPON CLOSER INSPECTION OF THE BLOODLINES A SMALL SECTION OF THE TUBING APPEARED TO BE PINCHED RESULTING IN A CRACK APPROXIMATELY 3 MM LONG. THE RN ALSO NOTED THAT THE MACHINE WAS MAKING A CLICKING NOISE PRIOR TO THE EVENT. THE BIOMED STATED DURING FOLLOW-UP THAT THE BLOOD PUMP ROTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169365 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 74 YR Female