BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1932706 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07053
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 26, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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 AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH NUTRINEAL PD4 VIAFLEX INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) TWIN BAGS FOR THE TREATMENT OF RENAL FAILURE SECONDARY TO PERIPHERAL VASCULAR DISEASE AND ATROPHIED KIDNEYS. ON (B)(6) 2010, WHILE RECEIVING NUTRINEAL PD4 VIAFLEX THERAPY, THE PATIENT EXPERIENCED STERILE PERITONITIS, MANIFESTED BY ABDOMINAL PAIN, GENERAL MALAISE AND CLOUDY EFFLUENT. ON (B)(6) 2010, THE PATIENT RECEIVED KEFZOL (250MG, 4 TIMES PER DAY, ROUTE NOT REPORTED) AND VANCOMYCIN (50MG, 4 TIMES PER DAY, ROUTE NOT REPORTED). ON (B)(6) 2010, THE PATIENT STILL EXPERIENCED CLOUDY EFFLUENT AND WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2010, VANCOMYCIN THERAPY WAS DISCONTINUED AND THE PATIENT WAS DISCHARGED TO HOME. KEFZOL CONTINUED. ON (B)(6) 2010, NUTRINEAL PD4 VIAFLEX THERAPY WAS DISCONTINUED, AND THE PATIENT'S EFFLUENT WAS CLEAR. NO DRUG ADDITIVES HAD BEEN ADDED TO THE PD SOLUTIONS, AND THE PATIENT DID NOT MIX ANY PD SOLUTIONS TOGETHER. NO EXIT SITE OR TUNNEL INFECTION WAS OBSERVED, AND THE PATIENT DID NOT ROUTINELY REUSE SUPPLIES. THE PATIENT HADN'T EXPERIENCED ANY OTHER EPISODES OF PERITONITIS WITHIN 4 WEEKS PRIOR TO THE CURRENT EPISODE, AND THERE WAS NO BREAK IN ASEPTIC TECHNIQUE. THE PHYSICIAN WAS UNABLE TO DETERMINE IF THE STERILE PERITONITIS RESOLVED BECAUSE KEFZOL WAS ONGOING. AN OUTCOME FOR THE EVENT OF GENERAL MALAISE WAS NOT REPORTED. ON AN UNREPORTED DATE, NUTRINEAL PD4 VIAFLEX WAS DISCONTINUED. THE LEUCOCYTE COUNTS DECREASED, THE PERITONEAL EFFLUENT IMPROVED AND THE PATIENT REPORTED THAT HE FELT BETTER. IT WAS NOT REPORTED WHAT OTHER PD SOLUTIONS WERE USED OR IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PHYSICIAN BELIEVED THAT THE EVENT OF STERILE PERITONITIS WAS MEDICALLY SIGNIFICANT AND RELATED TO NUTRINEAL PD4 VIAFLEX THERAPY. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY FOR THE EVENT OF GENERAL MALAISE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R ETALPHA, ACETYLSALICYLIC ACID,| UNSPECIFIED PRODUCT, HIBISCRUB, LASIX, PANTAZOL| NUTRINEAL PD4 VIAFLEX, PHYSIONEAL, ARANESP| BACTROBAN NOSE CREAM (MUPIROCIN CALCIUM)| DAVITAMON (ERGOCALCIFEROL), RENAGEL, ZESTRIL,| CALCHI-CHEW (CALCIUM CARBONATE),