BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1943338 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07509
    Event Type
    Injury
    Date Received
    December 31, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INCIDENT OF PERITONITIS WAS REPORTED WITH THE USE OF DIANEAL PD1 1.36% 2L TB. THE DIANEAL PD1 1.36% 2L TB HAS BEEN IDENTIFIED AS THE CAUSE OF THIS PERITONITIS. THE DIANEAL PD1 1.36% 2L TB LOT NUMBER INVOLVED IN THIS INCIDENT (10I20G44) HAS BEEN WITHDRAWN FROM THE MARKET DUE TO COMPLAINTS OF STERILE PERITONITIS. THIS IS NOT AN MDR REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ADDITIONAL INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) FROM (B)(6). IT WAS REPORTED BY THE PHYSICIAN THAT DURING THE LAST TWO WEEKS THE PATIENT SOMETIMES HAD CLOUDY DRAIN FLUID (DIALYSATES) AFTER USING DIANEAL PD1 ((B)(4), LOT # 10I20G44). THE PHYSICIAN REPORTS THAT AFTER CHANGING TO ANOTHER LOT, THE DIALYSATES CLEARED UP. THE PATIENT WAS NOT TREATED WITH ANTIBIOTICS. THE PATIENT'S PHYSICIAN ASSUMES THE CONTAMINATION OF THE SOLUTION OR THIS BATCH CAUSED CHEMICAL PERITONITIS IN THIS PATIENT. NO SAMPLE IS AVAILABLE FOR EVALUATION. AS THERE HAS BEEN NO CONFIRMATION THAT THIS WAS THE CAUSE OF THE PERITONITIS, THIS COMPLAINT WAS OPENED TO CAPTURE A DISPOSABLE DEVICE IN RELATION TO THE EVENT. HOSPITALIZATION WAS NOT NECESSARY . NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. LABORATORY TEST REVEALED: HOSPITALIZATION WAS NOT NECESSARY. PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD1