BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2110395 · Received June 1, 2011

    Report

    Report Number
    1423500-2011-06905
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF THE PERITONITIS WAS (B)(6) 2011. THE TYPE WAS BACTERIAL PERITONITIS AND THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. THE TRANSFER SET WAS PURCHASED FROM BAXTER HOWEVER, THE PERITONITIS WAS NOT CAUSED BY A DISCONNECT OR LEAK OF THE TRANSFER SET. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR AN UNSPECIFIED LENGTH OF THERAPY. DOSE AND ROUTE ARE UNSPECIFIED. THE REPORTED CAUSE OF THE PERITONITIS WAS NOTED TO BE A BREAK IN ASEPTIC TECHNIQUE. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. THE OUTCOME INDICATES THE PATIENT HAS RECOVERED FROM THE EVENT. NO CONCOMITANT MEDICATIONS WERE PROVIDED. THE NURSE INDICATED THE PERITONITIS WAS NOT DUE TO BAXTER DEVICES OR MEDICATIONS. NO FURTHER INFORMATION WILL BE PROVIDED REGARDING THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOT, H11D11089 AND H11C21031, WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE 3RD OF 3 REPORTS FOR THIS INCIDENT. THIS IS 3RD OF 3 REPORTS ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    DURING A PATIENT CALL ON (B)(6) 2011 REGARDING A LOW DRAIN VOLUME ALARM, THE PATIENT INDICATED HE HAD A PERITONEAL INFECTION. THE FACILITY NURSE WAS CONTACTED ON (B)(6) 2011 AND CONFIRMED THAT THE PATIENT HAD A PERITONEAL INFECTION RELATED TO PERITONEAL DIALYSIS THERAPY.

    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 47 YR Other (B)(4) 2.5% LO/CAL UB 2L/2L DIANEAL| (B)(4) EXTRANEAL PD-2 2L/3L| (B)(4) 4.25% LO/CAL UB 2L/2L DIANEAL| (B)(4) 4.25% LO/CAL 5L/5L DIANEAL| (B)(4) 2.5% LO/CAL 5L/5L DIANEAL| (B)(4) 1.5% LO/CAL 5L/5L DIANEAL| (B)(4) 1.5% LO/CAL UB 2L/2L DIANEAL| HOMECHOICE