BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO PD CYCLER

    MDR report key: 162369 · Received April 9, 1998

    Report

    Report Number
    162369
    Event Type
    Injury
    Date Received
    April 9, 1998
    Date of Event
    March 12, 1998
    Report Date
    March 16, 1998
    Manufacturer
    FMC
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT'S WIFE STATES THAT MACHINE MISSED THE FOURTH FILLING, SHE HAD SET MACHINE TO FILL PT WITH 2000CC SOLUTION AND DISCONTINUED TREATMENT FOR MORNING. WHEN CONNECTING FOR PAUSE EXCHANGE, IN THE EVENING, PT DRAINED 4730 ML AND EXPERIENCED CHEST PAIN. IT IS NOT REASONABLE TO REMOVE 4730 ML WITH ONE EXCHANGE. PT'S WIFE STATES THAT SHE SET MACHINE TO FILL AGAIN THAT AM. PT WAS SENT TO HOSP WITH CHEST PAIN. TECHNICAL SERVICE NOTIFIED. MACHINE WILL BE REMOVED FROM SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO PD CYCLER PD CYCLER KPF FMC FE6984 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention LC/LM 1NMC 2L 1.5% & 2.5% SOLUTION.| 2 LEAD ECHO SET.