BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1938292 · Received December 27, 2010

    Report

    Report Number
    1423500-2010-07262
    Event Type
    Injury
    Date Received
    December 27, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR 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 ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PERITONITIS EVENT REPORTED WITH USE OF DIANEAL. THE DIANEAL LOT DELIVERED TO THE PATIENT HAS BEEN WITHDRAWN FROM THE MARKET DUE TO COMPLAINTS OF STERILE PERITONITIS. THE DIANEAL HAS BEEN IDENTIFIED AS THE CAUSE OF THE PERITONITIS AND THERE IS NO ALLEGATION AGAINST THE DISPOSABLE DEVICES. THIS IS NOT A MDR REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM A (B)(6) PHYSICIAN (B)(6) 2010. THE PATIENT STARTED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS(CAPD) WITH DIANEAL PD1 ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT PRESENTED WITH CLOUDY PD EFFLUENT. THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS, BUT WAS NOT HOSPITALIZED OR TREATED WITH ANTIBIOTICS. THE PHYSICIAN DOCUMENTED THE CAUSE AS RELATED TO THE DIANEAL SOLUTION AND DEVICES THAT THE PATIENT HAD USED. IT WAS REPORTED THAT THE EFFLUENT CLEARED THE DAY AFTER THE PATIENT EXCHANGED LOTS OF THE DIANEAL. THE PATIENT DID NOT TAKE CONCOMITANT MEDICATION AND WAS FULLY RECOVERED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 500 INSTRUMENT PRODUCED AN ERRONEOUS DIFFERENTIAL (LOW NE% AND HIGH LY%) RESULT WITHOUT INSTRUMENT GENERATED FLAGS ON A SINGLE PATIENT SPECIMEN. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE DOCTOR QUESTIONED THE DIFFERENTIAL RESULTS. THE OPERATOR RERAN THE SPECIMEN AND VERIFIED THE RESULTS SLIDE REVIEW. THE RERUN INSTRUMENT RESULTS WERE SENT OUT AS CORRECTED RESULTS, WHICH THE CUSTOMER BELIEVES ARE CORRECT. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DIANEAL PD1