BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2210675 · Received August 12, 2011

    Report

    Report Number
    1423500-2011-10673
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H11C10067 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 THROUGH CAPA (B)(4).

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL BY BAXTER PRODUCT SURVEILLANCE ON A SEPARATE REPORT OF PERITONITIS ON THE SAME PATIENT, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE PATIENT'S PERITONEAL DIALYSIS NURSE (PDN). THE PDN REPORTED THE PATIENT EXPERIENCED A SEPARATE EPISODE OF PERITONITIS IN (B)(6) 2011, WHICH WAS MOST LIKELY DUE TO A BREAK IN ASEPTIC TECHNIQUE COINCIDENT WITH DIANEAL 2.5 AMBUFLEX AND EXTRANEAL THERAPIES. THE PATIENT WAS DIAGNOSED WITH THIS EPISODE OF BACTERIAL PERITONITIS ON (B)(6) 2011 AND WAS NOT HOSPITALIZED. ON AN UNREPORTED DATE THE PATIENT BEGAN TREATMENT WITH DIANEAL 2.5 AMBUFLEX AND EXTRANEAL THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED). THE PATIENT WAS RECEIVING HIS TREATMENT USING THE HOMECHOICE CYCLER. THE PDN STATED THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH AN UNSPECIFIED ANTIBIOTIC (DOSE AND FREQUENCY NOT REPORTED). THE PDN STATED THE PROBABLE CAUSE OF PERITONITIS WAS CONTAMINATION/ BREAK IN ASEPTIC TECHNIQUE. THE PDN ADDED THAT THE PRIMARY CAREGIVER IS THE PATIENT'S WIFE AND IF THE WIFE IS NOT AVAILABLE, IT IS POSSIBLE THAT AN UNTRAINED FAMILY MEMBER COULD STEP IN TO HELP WITH THE THERAPY. THE NURSE ADDED THE PATIENT IS NOT CAPABLE OF DOING HIS OWN THERAPY. DIANEAL 2.5 AMBUFLEX AND EXTRANEAL THERAPIES WERE ONGOING. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. THE OUTCOME OF THE BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO A DIANEAL 2.5 AMBUFLEX, EXTRANEAL, HOMECHOICE THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention EXTRANEAL| DIANEAL 2.5 AMBUFLEX| HOMECHOICE