BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4120177 · Received September 25, 2014

    Report

    Report Number
    1416980-2014-33274
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PEDIATRIC PATIENT EXPERIENCED STERILE PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS TREATED WITH SEFAZOL (ACTIVE SUBSTANCE: CEFAZOLIN SODIUM) (125MG/L TWICE A DAY; ROUTE AND DURATION NOT REPORTED) AND ZIDIM (ACTIVE SUBSTANCE: CEFTAZIDIME) (125MG/L TWICE A DAY; ROUTE AND DURATION NOT REPORTED) FOR PERITONITIS. THERAPY WAS ONGOING. THE PATIENT RECOVERED 18 DAYS AFTER THE ONSET OF THE EVENT. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT AND PATIENT OUTCOME WAS NOT REPORTED. ACTION TAKEN WITH PD THERAPY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 4 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598303 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other| R HOMECHOICE| TRANSFER SET, CASSETTE, TITANIUM ADAPTER| DIANEAL PD4 2.27%