BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3010321 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-05978
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, NO BATCH REVIEW COULD BE PERFORMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR BECAUSE THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THERAPY ASSISTANCE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 2 OF 4. THE CAREGIVER (CG) STATED THAT WHEN SHE WOKE UP THE HOME PATIENT (HP) HAD DISCONNECTED. THE CG STATED THAT THE HP DISCONNECTED HIMSELF DURING DRAIN 2 OF 4 AND WENT INTO THE LIVING ROOM AND SAT DOWN. THE CG STATED THAT THE HP IS DISORIENTED WHEN HE WAKES AND DID NOT THINK THE HP USED ASEPTIC MEASURES WHEN DISCONNECTING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE CG REGARDING THE REPORTED EVENT. THE CG STATED THAT THE HP HAS SUNDOWNERS SYNDROME AND THAT WAS WHY THE HP WAS DISORIENTATED. THE HP CAPPED THE TRANSFER SET, BUT THE CG COULD NOT BE SURE THAT THE HP DID NOT TOUCH/CONTAMINATE THE TRANSFER SET BEFORE CAPPING. THE CG TOOK THE HP TO THE REGISTERED NURSE (RN) AND THE RN REPLACED THE TRANSFER SET. THE CG STATED THAT THE RN ALSO HAD THE HP DUE A MANUAL BAG WITH ANTIBIOTICS IN IT AS A PRECAUTIONARY MEASURE. THE CG DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113493 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOME CHOICE