BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2060343 · Received April 16, 2011

    Report

    Report Number
    1423500-2011-04610
    Event Type
    Injury
    Date Received
    April 16, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REGULATORY REPORT BY A PHYSICIAN FROM THE (B)(4) HEALTH AUTHORITIES FROM (B)(4) INITIALLY RECEIVED BY A NURSE OF NAUSEA, VOMITING, DIARRHEA AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR ENTEROCOCCUS FAECALIS IN A EUROPEAN PATIENT COINCIDENT WITH DIANEAL, UNKNOWN THERAPY. ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL, UNKNOWN (20 LITERS, DAILY) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). THE NURSE CONTACTED A BAXTER SALES REPRESENTATIVE TO REPORT THAT THE PATIENT HAD GONE TO THE HOSPITAL ON (B)(6) 2011 FOR THE COMPLAINT OF ABDOMINAL PAIN, NAUSEA AND VOMITING. THE PATIENT'S EFFLUENT WAS INITIALLY CLEAR, AND LATER BECAME CLOUDY (DATE NOT REPORTED). ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH GLAZIDIME (CEFTAZIDIME, 2 GM, FREQUENCY AND ROUTE UNKNOWN) AND TOTACEF (CEFAZOLINE, 2GM, FREQUENCY AND ROUTE UNKNOWN). ON (B)(6) 2011, THE PATIENT STOPPED THERAPY WITH GLAZIDIME AND TOTCEF. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH GLAZIDIME (CEFTAZIDIME, 1.5GM, IP, FREQUENCY UNKNOWN) AND CEFAZOLINE (1.5GM, IP, FREQUENCY UNKNOWN). ON (B)(6) 2011, THE PATIENT STOPPED THERAPY WITH GLAZIDIME AND TOTCEF, AND BEGAN VANCOMYCIN (2G, EVERY 5 DAYS, IP) FOR THE ENTEROCOCCUS FAECALIS. AT THE TIME OF REPORTING, THE PATIENT CONTINUED THERAPY WITH VANCOMYCIN. THE PATIENT HAD REPORTED TO THE NURSE THAT WHILE INSERTING THE SPIKE (BEFORE STARTING THERAPY) HE HAD REALIZED THAT THE WHITE OVAL PORTION OF THE CONNECTOR WAS NOT COMPLETELY SEALED. THE PATIENT TRIED TO TURN THE BAG UPSIDE DOWN, AND BECAUSE THE BAG DID NOT LEAK HE DECIDED TO START THERAPY. UPON FOLLOW UP, THE PHYSICIAN REPORTED THAT THE PATIENT HAD ADDITIONALLY EXPERIENCED DIARRHEA, AND WAS DIAGNOSED WITH BACTERIAL PERITONITIS, MANIFESTED BY ABDOMINAL PAIN. THE PHYSICIAN STATED THAT ON (B)(6) 2011, AS SOON AS THE PATIENT ARRIVED AT THE FIRST AID STATION, HE WAS TREATED WITH CONTRAMAL (TRAMADOL, 100MG, IM, FREQUENCY UNKNOWN) AND PLASIL (METOCLOPRAMIDE, IM, DOSE AND FREQUENCY UNKNOWN). THE EVENTS OF VOMITING, DIARRHEA AND BACTERIAL PERITONITIS WERE RESOLVING. AN OUTCOME FOR THE EVENT OF NAUSEA WAS NOT REPORTED BY THE PHYSICIAN, BUT THE NURSE STATED THAT THE NAUSEA HAD NOT RESOLVED. DIANEAL, UNKNOWN THERAPY, CONTINUED AT THE SAME DOSE. . THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENTS OF VOMITING, DIARRHEA AND BACTERIAL PERITONITIS. THE PHYSICIAN DID NOT ACKNOWLEDGE THE COMPLAINT OF NAUSEA. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2011 FROM THE (B)(4) HEALTH AUTHORITIES WHICH ADDED THE CAUSALITY ASSESSMENT OF PROBABLE THAT THE ADVERSE EVENTS COULD POSSIBLY BE DUE TO A DEFECTIVE BAG CONNECTOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R PLAVIX (CLOPIDOGREL)| DIANEAL| TORVAST (ATORVASTATIN)| IPERTEN (MANIDIPINE)| CARDIOASPIRIN (ACETYLSALICYLIC ACID)| ENAPREN (ENALAPRIL)| FERRO-GRAD (IRON SULFATE)