BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1862299 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04211
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 20, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2010, THE NURSE CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THE PATIENT WAS HOSPITALIZED (DATE NOT PROVIDED) DUE TO PERITONITIS. ON (B)(6) 2010, THE PHYSICIAN PROVIDED FURTHER INFORMATION. THE PHYSICIAN CONFIRMED THAT, ON AN UNKNOWN DATE, THE PATIENT HAD DEVELOPED PERITONITIS AND WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE NOT REPORTED). THE PHYSICIAN BELIEVED THAT THE "PERITONITIS WAS A POSSIBLE COMPLICATION OF PD THERAPY ITSELF, NOT OF PERITONEAL SOLUTION". THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE EVENT OF PERITONITIS WAS RESOLVING AND PD THERAPY CONTINUED UNCHANGED. THE PHYSICIAN CONSIDERED THE EVENT WAS CAUSED BY ASEPTIC TECHNIQUE (THIS WAS THE THIRD PERITONITIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL VIAFLEX AND DIANEAL-N PD2 1.5%