BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 1661729 · Received April 19, 2010

    Report

    Report Number
    1423500-2010-00502
    Event Type
    Injury
    Date Received
    April 19, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Removal / Correction Number
    1423500-01/08/10-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).DEVICE NOT RETURNED EVALUATION WILL NOT BE DONE.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS AN ONGOING CAPA INVESTIGATION, (B)(6), ASSOCIATED WITH THIS REPORT. THE CORRECTION AND REMOVAL (C AND R) NUMBER IS 1423500-01/08/10-001-C.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THAT THEY RECEIVED THE FIELD CORRECTIVE ACTION (FCA) LETTER DATED JANUARY 8, 2010 AND STATED THAT THE WIFE HAS BEEN OVERFILLED IN THE PAST DURING THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROGRAM, CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD), TOTAL VOLUME (TV)=12000ML, FILL VOLUME (FV)=2200ML, LAST FILL VOLUME (LFV)=1000ML, CYCLES 5. CAREGIVER SAID THAT HP DOES MID DAY EXCHANGE, FV=1500. TSR ASKED HP WHEN THE LAST TIME WAS THAT HP FELT OVERFILLED. CAREGIVER SAID ABOUT A MONTH AGO AND IT WAS USUALLY IN THE FIRST COUPLE OF CYCLES. TSR REVIEWED INITIAL DRAIN ALARM (IDA)=50. TSR EXPLAINED IDA AND PROGRAM TO CAREGIVER, TSR SUGGESTED THAT THE CAREGIVER FOLLOW UP WITH THE NURSE (RN) TO INCREASE THE IDA. THE TSR EXPLAINED THE LETTER TO CAREGIVER. ON 3/29/2010, PRODUCT SURVEILLANCE RECEIVED ADDITIONAL INFORMATION FROM GLOBAL PHARMACOVIGILANCE (GPV). GPV OBTAINED INFORMATION FROM THE NURSE WHO STATED THAT THE MACHINE STARTED TO FILL 2000ML AND THE MACHINE STARTED ANOTHER FILL WITHOUT DRAINING. PATIENT NOTICED ABDOMINAL DISTENTION AND DISCOMFORT. HUSBAND (B) (6) BYPASSED AND COMPLETED MANUAL DRAIN. THE NURSE INDICATED THAT THE OUTCOME WAS RESOLVED. ACCORDING TO THE NURSE, IT WAS UNKNOWN IF THE EVENT WAS RELATED TO THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention