BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2922858 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01421
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 REQUESTED. 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). ADDITIONAL INFORMATION:THIS CONDITION WAS NOT CONFIRMED, AS THE DISPOSABLE SET WAS NOT RETURNED FOR EVALUATION. ALSO THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED PROBLEM. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOTS H12J09064 AND H12J17026 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION RECEIVED FROM A NURSE IN THE USA OF PATIENT MADE THE MISTAKE OF TOUCH CONTAMINATION (REPORTED BY THE CONSUMER ONLY) AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 1.5% LOW CALCIUM AMBUFLEX AND DIANEAL PD4 2.5%, LOW CALCIUM AMBUFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 1.5% LOW CALCIUM AMBUFLEX AND DIANEAL PD4 2.5%, LOW CALCIUM AMBUFLEX THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL THERAPY WAS DISCONTINUED. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE PATIENT'S HUSBAND. ON AN UNREPORTED DATE, THE PATIENT MADE THE MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED), WHICH CAUSED PERITONITIS ON (B)(6) 2012. ON THAT SAME DAY, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AS REPORTED, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED AT THE TIME OF THE INITIAL CALL. ON (B)(6) 2013, BAXTER PRODUCT SURVEILLANCE CONTACTED THE PD NURSE (PDN) AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION. THE PDN CONFIRMED THE PERITONITIS EVENT AND STATED THE PATIENT HAS RECOVERED FROM THE PERITONITIS. THE PDN DECLINED TO PROVIDE INFORMATION AS TO WHETHER THE PATIENT WAS RE-TRAINED IN PROPER ASEPTIC TECHNIQUE FURTHER CLARIFYING THE CAUSE OF THE PERITONITIS WAS NOT DUE TO A BREAK IN ASEPTIC TECHNIQUE OR TOUCH CONTAMINATION (AS REPORTED BY CONSUMER). THE PDN STATED "THE PATIENT HAS OTHER THINGS GOING ON" (SPECIFICS NOT PROVIDED). THE PDN STATED THE CAUSE OF THE PERITONITIS WAS DUE TO A MEDICAL CONDITION OF THE PATIENT (THE PDN DECLINED TO PROVIDE FURTHER DETAILS ON THE CONDITION). THE PDN VERIFIED THE CAUSE OF THE PERITONITIS WAS NOT DUE TO A BAXTER DEVICE OR SOLUTION AND STATED "IN NO WAY DID THE CAUSE OF THE PERITONITIS HAVE ANYTHING TO DO WITH A BAXTER PRODUCT." THE PDN DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28180 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization DIANEAL PD4 1.5% LOW CALCIUM AMBUFLEX| DIANEAL PD4 2.5% LOW CALCIUM AMBUFLEX