BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1903746 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06038
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. THIS IS REPORT 6 OF 6 FOR THIS PERITONITIS EPISODE.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING FOLLOW-UP FOR AN UNRELATED ISSUE, THE PATIENT'S NURSE INDICATED THE PATIENT WAS BEING TREATED FOR PERITONITIS. THE NURSE STATED THE PATIENT NEEDED TO HAVE ANOTHER DOSE OF ANTIBIOTICS AND WAS CONTINUING WITH THERAPY. THE NURSE STATED THE PATIENT HAS NOT REPORTED ANY SYMPTOMS. THE NURSE STATED THE PATIENT WAS DOING WELL WITH THE FOLLOWING TREATMENTS. THE NURSE THEN STATED SHE DID NOT WANT TO BE CONTACTED ABOUT THE PATIENT AND NO OTHER INFORMATION WOULD BE PROVIDED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING FILL. THE HP STATED THAT THE HEATER LINE WAS NOT ALL THE WAY INTO THE HEATER BAG AND FLUID WAS LEAKING OUT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER TO END THERAPY AND EXPLAIN THE ALARM. THE HP STATED THEY WOULD DO A MANUAL DRAIN. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. FOLLOW UP WAS DONE VIA PHONE CALL; THE HP STATED THAT THEY CONTINUED THERAPY WITH HOMECHOICE (HC) USING NEW SUPPLIES. THE HP DID NOT NOTICE ANYTHING WRONG WITH THE BAG OR THE CASSETTE. SHE THINKS THERE WAS A KINK IN THE BAG AND THAT WAS WHY SHE WAS NOT ABLE TO SPIKE THE BAG. THE LOT NUMBER WAS UNAVAILABLE. THERAPY HAS BEEN GOING WELL SINCE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXD II SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention