BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2220900 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11129
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 4, 2011
    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 BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H10J25088 AND H10J17507 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THIS COMPLAINT FOR A REPORT OF PERITONITIS IS CONFIRMED BECAUSE IT WAS REPORTED THAT THE PATIENT HAD TOUCH CONTAMINATION, WHICH IS A BREAK IN ASEPTIC TECHNIQUE, WHICH IS A USE ERROR THAT CAN CAUSE PERITONITIS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF A PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WHEN HE WENT FOR CATHETER REPLACEMENT SURGERY. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR FIVE WEEKS. THE OUTCOME FOR THE MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED AND THE PERITONITIS WAS RECOVERING. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE CONSUMER STATED THAT PERITONITIS WAS DUE TO THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R DIANEAL PD2 AMBUFLEX| HOMECHOICE