BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3230702 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18733
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR EVALUATION. PER THE HOMECHOICE PATIENT AT HOME GUIDE, THE PATIENT IS INSTRUCTED TO PLACE A MINICAP ON THEIR TRANSFER SET IMMEDIATELY AFTER DISCONNECTING FROM THE HOMECHOICE. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) MADE A USE ERROR / BREACH IN ASEPTIC TECHNIQUE WHILE PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. THIS OCCURRED ON THE HOMECHOICE DEVICE DURING DWELL 2 OF 9. THE HP DID NOT PUT A MINICAP ON. THE CUSTOMER CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) TO REQUEST ASSISTANCE AND THE TSR ASSISTED THE HP TO DISCONNECT AND END THERAPY. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330061 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR HOMECHOICE| MINICAP TRANSFER SET