BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIT-LINE BLOOD CHAMBER

    MDR report key: 4230796 · Received October 24, 2014

    Report

    Report Number
    2937457-2014-03037
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    P935958
    Removal / Correction Number
    Z-1716-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A PRODUCT RECALL HAS BEEN INITIATED BY THE MANUFACTURER AND THE REPORTED PRODUCT ISSUE IS BEING INVESTIGATED BY THE MANUFACTURER VIA A CAPA.

    Description of Event or Problem · 1

    A CLINICAL MGR OF A CHRONIC HEMODIALYSIS UNIT NOTIFIED THE PRODUCT COMPLAINT DEPT OF A CRIT LINE BLOOD CHAMBER SEPARATION FROM A DIALYZER DURING A HEMODIALYSIS TREATMENT WHICH CAUSED APPROX 300 ML ESTIMATED BLOOD LOSS. ACCORDING TO FOLLOW UP OBTAINED FROM THE CLINIC MGR, THIS EVENT OCCURRED APPROX 2 HOURS INTO THE 3 HOUR 15 MINUTE TREATMENT. SHE STATED THE CERTIFIED HEMODIALYSIS TECH NOTICED THE CHAMBER APPEARED "LOOSE." THE TREATMENT WAS ENDED EARLY. THE PT REPORTEDLY STATED SHE FELT "WEAK" AS IF FROM LOW BLOOD PRESSURE; HOWEVER, NO BLOOD PRESSURE READINGS WERE MADE AVAILABLE. THE PT WAS TREATED WITH APPROX 500 ML NORMAL SALINE SOLUTION AND REPORTED FEELING BETTER. NO FURTHER MED INTERVENTION WAS REQUIRED. SUBSEQUENTLY THE PT COMPLETED HER HEMODIALYSIS TREATMENTS WITHOUT ISSUE. THE CHAMBER WAS DISCARDED AND IS NOT AVAILABLE FOR MFR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677986 CRIT-LINE BLOOD CHAMBER KOC FRESENIUS MEDICAL CARE NORTH AMERICA 14061305

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR FRESENIUS ACID AND BICARB PRODUCT| FRESENIUS DIALYZER| FRESENIUS COMBISET BLOODLINES| FRESENIUS SALINE