BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 4153391 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-35071
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NOTED CRACKS ON THE SIDE OF THE CASSETTE WITHOUT ANY SIGN OF PHYSICAL DAMAGE. PRESSURE TESTING WAS PERFORMED AND A LEAK WAS VERIFIED AT THE CRACK ON THE SIDE OF THE CASSETTE. SAMPLE ANALYSIS VERIFIED THE REPORTED EVENT. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBER S14D07068 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE EVENT WAS A CRACKED CASSETTE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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) EXPERIENCED A LEAK FROM THE CASSETTE ON THE HOMECHOICE DEVICE, DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631306 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE S14D07068

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE