BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1984370 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01761
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS (H10J07011, H10I15098) WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE USE-ERROR POOR ASEPTIC TECHNIQUE. THE CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS PATIENTS DISCARD SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A CALL FOR AN UNRELATED COMPLAINT ON (B)(6) 2011, THE PATIENT REPORTED THAT HE HAD SURGERY LAST WEEK. HE STATED THAT HE HAD PERITONITIS AND THE CATHETER WAS REMOVED, CLEANED AND REINSERTED. THE PATIENT RECEIVED HEMODIALYSIS WHILE HE WAS IN THE HOSPITAL. ON (B)(6) 2011 BAXTER RECEIVED A PHONE CALL FROM THE PATIENT'S PERITONEAL DIALYSIS NURSE WHO CONFIRMED THAT THE PATIENT HAD PERITONITIS IN (B)(6) 2010. SHE REPORTED THAT ON (B)(6) 2010 THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND THE PERITONEAL DIALYSIS EFFLUENT WAS SENT FOR GRAM STAIN, CULTURES AND CELL COUNTS. THE PATIENT WAS TREATED WITH VANCOMYCIN ON UNKNOWN DATES FOR THIS PERITONITIS. SHE REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2010 TO (B)(6) 2010 FOR ABDOMINAL PAIN RELATED TO GALL STONES. SHE STATED THAT DURING THIS HOSPITAL STAY THE PATIENT WAS SCHEDULED FOR LAPAROSCOPIC CHOLECYSTECTOMY AND DURING THE PROCEDURE WAS FOUND TO HAVE TOO MANY ADHESIONS TO PERFORM THE PROCEDURE. SHE REPORTED THAT THE GALL STONES WERE NOT RELATED TO PERITONEAL DIALYSIS THERAPY. TREATMENT FOR THE PERITONITIS WAS ONGOING. PERITONEAL DIALYSIS THERAPY WAS RESTARTED AND SUBSEQUENTLY STOPPED BECAUSE THE PATIENT WAS NOT DRAINING WELL. THE PATIENT WAS STARTED ON HEMODIALYSIS AND WILL REMAIN ON THIS THERAPY. THE PERITONEAL DIALYSIS CATHETER WAS REMOVED AND A PERMA CATH INSERTED ON AN UNKNOWN DATE IN (B)(6) 2010. THERE WAS NO ALLEGATION AGAINST ANY BAXTER DEVICES OR SOLUTION. THE PERITONEAL DIALYSIS NURSE STATED THAT THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION. THE PATIENT HAS RECOVERED FROM THIS EPISODE OF PERITONITIS. THERE WAS NO FURTHER INFORMATION AVAILABLE.

    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 Hospitalization| R (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| HOME CHOICE CYCLER