BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECO SET 2PRONG W/2PREFILL 30/C

    MDR report key: 285084 · Received June 20, 2000

    Report

    Report Number
    1713747-2000-00202
    Event Type
    Injury
    Date Received
    June 20, 2000
    Date of Event
    May 15, 2000
    Report Date
    May 31, 2000
    Manufacturer
    MEDISYSTEMS
    Product Code
    KDJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM CUSTOMER SERVICE INDICATES THAT THE PT'S PARENT CALLED TO REPORT THAT THE TUBING WAS LEAKING ALTHOUGH NO HOLE WAS VISIBLE. THE LEAK OCCURRED AT THE SNAP CONNECTION CLOSEST TO THE MACHINE. THE PT AWOKE AND WAS FOUND WET AND LEAKAGE WAS FOUND COMING FROM TUBING. CUSTOMER SERVICE INDICATES THAT THE PT'S PARENT HAS THE SAMPLE. HOWEVER, PT'S PARENT IS RETAINING THE SAMPLE PENDING THE DETERMINATION OF WHETHER THE PT HAS AN INFECTION. FOLLOW-UP REQUIRED. 5/31/00 QUALITY SYSTEMS CALLED RN AT FACILITY TO CONFER ABOUT KNOWN DETAILS OF INCIDENT. RN DID NOT SEE SAMPLE OF TUBING TO EVALUATE THE LEAK, BUT PT WAS BROUGHT INTO CENTER FOR ANTIBIOTICS (CEFAZOLIN 500MG IP X 1 ON 5/14/00). THE PT REMAINED ASYMPTOMATIC. PT'S EFFLUENT SOLUTION WAS CLEAR AND CULTURE OF EFFLUENT WAS WITHOUT GROWTH OR NEGATIVE. 5/31/00: QUALITY SYSTEMS SPOKE WITH PT AND REQUESTED THAT PT'S PARENT CALL QUALITY SYSTEMS RE: SAMPLE AVAILABILITY. 6/2/00: QUALITY SYSTEMS CALLED PARENT AND REQUESTED COMPLAINT SAMPLE. PARENT IS REFUSING TO PROVIDE SAMPLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECO SET 2PRONG W/2PREFILL 30/C TUBING SET FOR PERITONEAL CYCLER KDJ MEDISYSTEMS NA 9123103

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other| R FREEDOM PD PLUS CYCLER.