BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2132833 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07781
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10L07124 AND H10J01105 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE 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.

    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 REQUESTED. 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

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PATIENT MADE MISTAKE/ TOUCH CONTAMINATION AND PERITONITIS WITH (B)(6) IN A PATIENT (AGE NOT REPORTED) COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX (LOT NUMBERS, DOSES AND FREQUENCIES NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING INFORMATION WAS REPORTED. ON AN UNREPORTED DATE THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. IN (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS REPORTED AS PATIENT MADE MISTAKE/ TOUCH CONTAMINATION. TREATMENT WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. ON AN UNREPORTED DATE IN 2011, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. PD THERAPIES WERE ONGOING. THE NURSE STATED THAT THE EVENTS OF PERITONITIS AND TOUCH CONTAMINATION WERE NOT RELATED TO DIANEAL AND EXTRANEAL THERAPIES AND DID NOT COMMENT ON THE EVENT OR OUTCOME OF 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 66 YR Hospitalization EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX