BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1963250 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00757
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    May 1, 2010
    Report Date
    November 12, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION HAS NOT BEEN PROVIDED REGARDING THE PRODUCT(S) IN USE BY THE PATIENT AT THE TIME OF THIS EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE PRODUCT CODE IS UNKNOWN, THEREFORE, A 510K NUMBER CANNOT BE PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT NUMBER WAS NOT PROVIDED THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    INITIALLY, THE CALL WAS RECEIVED FOR AN UNRELATED ISSUE. BAXTER'S GLOBAL PHARMACOVIGILANCE (GPV) OBTAINED THE FOLLOWING INFORMATION: A FACILITY NURSE REPORTED A GASTROINTESTINAL (GI) BLEED AND PERITONITIS IN (B)(6) MALE PATIENT WHILE ON PERITONEAL DIALYSIS THERAPY. ON (B)(6) 2008, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPY INTRAPERITONEALLY (IP). IN (B)(6) 2010, THE PATIENT EXPERIENCED GI BLEEDING AND WAS HOSPITALIZED FROM (B)(6) 2010 THROUGH (B)(6) 2010. WHILE HOSPITALIZED, THE PATIENT UNDERWENT A COLONOSCOPY. ON (B)(6) 2010, THE PATIENT WAS READMITTED TO THE HOSPITAL AND DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON (B)(6) 2010, DIANEAL PD4 AMBUFLEX THERAPY WAS WITHDRAWN AND THE PATIENT WAS PLACED ON HEMODIALYSIS. IN (B)(6) 2010, THE EVENTS RESOLVED. ON (B)(6) 2010, PERITONEAL DIALYSIS THERAPY WAS RESTARTED. THE REPORTER WAS UNABLE TO ASSESS WHETHER THE GI BLEED AND PERITONITIS WERE RELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    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 83 YR Hospitalization| R (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%.| DIALYVIT (RENAL TABS)| EPOGEN 10,000| METOPROLOL| FISH OIL| TUMS| AMLODIPINE, DAILY