BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2150294 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08692
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    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 2 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR LOT NUMBERS H11C26055 AND H11B24052 WITH NO ISSUES OR EXCEPTIONS NOTED. A BATCH REVIEW CONDUCTED FOR LOT NUMBER H11A24039 REVEALED AN EXCEPTION BUT DOES NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF A PATIENT MADE WHO MISTAKE/TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. ON (B)(6) 2011, THE PATIENT WAS RECOVERING AND DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL TAKING ANTIBIOTICS (DRUG, DOSE, START DATE NOT REPORTED). THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND THE OUTCOME FOR THE MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY AND WAS DUE TO THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION.

    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 22 YR Hospitalization| R DIANEAL PD2 AMBUFLEX| HOMECHOICE