BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4113255 · Received September 24, 2014

    Report

    Report Number
    1416980-2014-32981
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN. AS A RESULT, THE SERVICE HISTORY REVIEW AND/OR DEVICE HISTORY REVIEW WERE NOT PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED RESPIRATORY DISTRESS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR RESPIRATORY DISTRESS AND OTHER UNRELATED INDICATIONS. TREATMENT AND PATIENT OUTCOME FOR THE RESPIRATORY DISTRESS WAS NOT REPORTED. ACTION TAKEN WITH PD THERAPY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593330 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization DIANEAL 1.5% PD4 SINGLEBAG,| DIANEAL 2.5% PD4 SINGLEBAG