BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1923410 · Received December 13, 2010

    Report

    Report Number
    1423500-2010-06854
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4), 2010, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) USING DIANEAL PD2 AMBUFLEX NIGHTLY, INTRAPERITONEAL. IN (B)(4) OF 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH CEFAZOLIN IP FOR FOUR WEEKS AND HIS SYMPTOMS OF CLOUDY EFFLUENT AND ABDOMINAL PAIN RESOLVED IMMEDIATELY. THERE WAS NO EXIT SITE OR TUNNEL INFECTION AND THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT. THE PATIENT REMAINED ON PD THERAPY WITH NO INTERRUPTION IN THERAPY. THE REPORTER DIDN'T SEE HOW THE DIALYSIS SOLUTION OR HOMECHOICE MACHINE COULD HAVE CAUSED THE EVENT OF PERITONITIS HOWEVER SHE COULD NOT RULE IT OUT. THERE HAD BEEN NO IDENTIFIABLE CAUSE FOR THE PERITONITIS; THE WIFE WAS METICULOUS; HOWEVER THE PATIENT WAS KNOWN FOR DISCONNECTING HIMSELF FROM PD THERAPY. IT WAS ALSO THOUGHT THE PATIENT'S ABDOMEN MAY HAVE BEEN COLONIZED WITH (B)(6). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOTS (H10A28031 AND H10D16089) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE CARE GIVER OF THE HOME PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE REPRESENTATIVE (TSR) BECAUSE THE PATIENT WAS HAVING PROBLEMS DRAINING. DURING THE CALL, THE CARE GIVER STATED THAT THE PATIENT HAS HEPARIN AND ANTIBIOTIC IN THE SOLUTION BAGS DUE TO THE PATIENT HAVING PERITONITIS. THIS COMPLAINT IS OPENED TO INVESTIGATE THE REPORT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention REGULAR CALCIUM (PD2) AMBUFLEX