BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2910953 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00880
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM THE RENAL NURSE AS FOLLOWS. PER THE NURSE THE PERITONITIS WAS DUE TO AN EVENT OF TOUCH CONTAMINATION OF THE OPEN ACCESS (DETAILS NOT PROVIDED). THE NURSE CONFIRMED THAT THE PATIENT IS NOW RE-TRAINED (DATE UNSPECIFIED) FOR ASEPTIC PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS CONDITION WAS CONFIRMED, AS THE NURSE REPORTED A BREAK IN ASEPTIC TECHNIQUE BY THE CUSTOMER (DESCRIBED AS TOUCH CONTAMINATION). THEREFORE THE ASSIGNABLE CAUSE WAS A BREAK IN ASEPTIC TECHNIQUE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE UNITED KINGDOM OF PERITONITIS AND USE ERROR COINCIDENT WITH UNSPECIFIED DIANEAL THERAPY. INITIALLY THE PATIENT CONTACTED BAXTER CUSTOMER SERVICE TO REQUEST ASSISTANCE WITH AN UNRELATED ALARM WHICH OCCURRED ON THE HOMECHOICE DURING USE FOR PERITONEAL DIALYSIS (PD) THERAPY. DURING THE CONVERSATION, THE PATIENT, WHO USES ROYAL DERBY HOSPITAL, STATED HE IS IN THE HOSPITAL THAT DAY WITH PERITONITIS. THE PATIENT REPORTED, THE NURSE DID A MANUAL EXCHANGE WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY, AND LOT NOT REPORTED). THE VOLUME OF THE SOLUTION EXCHANGE AND ANTIBIOTICS WAS NOT SPECIFIED. ON (B)(6) 2013, THE RENAL NURSE STATED THAT "IT SEEMS THE CAUSE OF THE PERITONITIS FOR THIS PATIENT WAS PATIENT ERROR (DETAILS NOT PROVIDED) BECAUSE THE ORGANISM GROWN WAS A SKIN CONTAMINANT" (UNSPECIFIED). IT WAS REPORTED, THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18815 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL