BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3191460 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16499
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION - TREATMENT WITH CEFTAZIDIME AND VANCOMYCIN WAS DISCONTINUED. TWO DAYS AFTER VANCOMYCIN WAS DISCONTINUED, THE PATIENT EXPERIENCED A RECURRENCE OF PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT AND MILD ABDOMINAL PAIN. ON THE SAME DAY, THE PATIENT WAS TREATED FOR THE RECURRENCE OF PERITONITIS WITH CEFTAZIDIME (INTRAPERITONEALLY (IP), 1G/DAY) AND FLUCONAZOLE (ORAL, 50MG/DAY). THREE DAYS LATER, VANCOMYCIN (IP, 2G/DAY) WAS INITIATED FOR PERITONITIS. THE PATIENT COMPLETED THERAPY WITH CEFTAZIDIME AND FLUCONAZOLE THERAPIES WERE DISCONTINUED, BUT THERAPY WITH VANCOMYCIN (IP, 2G EVERY 5 DAYS) WAS MAINTAINED. THE OUTCOME OF THE RECURRENT PERITONITIS WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WAS TREATED WITH VANCOMYCIN FOR THIRTY DAYS (DOSE AND ROUTE NOT REPORTED).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE PATIENT EXHIBITED A PUSTULE WITH YELLOWISH EXUDATE DRAINAGE OF THE ABDOMINAL ABSCESS. ON THE SAME DAY, ORAL ANTIBIOTIC THERAPY WITH CIPROFLOXACIN (500 MG/DAY) WAS INITIATED. A COUPLE OF DAYS LATER THE PATIENT EXPERIENCED A RECURRENCE OF PERITONITIS, WHICH MANIFESTED AS CLOUDY EFFLUENT. VANCOMYCIN TREATMENT (ADMINISTERED INTRAPERITONEALLY (IP), 2 G, EVERY 5 DAYS) WAS MAINTAINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL FOLLOW UP INFORMATION WAS RECEIVED FROM A NURSE. IT WAS REPORTED THAT THE PATIENT DISCONTINUED THE CEFTAZIDIME (IP, 1G/DAY) TREATMENT. HOWEVER, THE PATIENT CONTINUED TO BE TREATED WITH VANCOMYCIN (IP, 2G, EVERY FIVE DAYS). ON AN UNREPORTED DATE, THE PERITONEAL DIALYSIS (PD) THERAPY WAS WITHDRAWN. AS A RESULT, THE PATIENT STARTED HEMODIALYSIS. A DAY LATER, THE PATIENT HAD A SURGERY WHERE THE ABDOMINAL ABSCESS WAS CLEANED AND THE NON-BAXTER CATHETER WAS REMOVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REPORTED REGARDING THIS EVENT. DESPITE NOT HAVING SYMPTOMS, IT WAS LATER REPORTED THAT THE PATIENT MAINTAINED THEIR PERITONITIS. THE PATIENT ALSO MAINTAINED A LOCAL ABDOMINAL ABSCESS WITH A SMALL PUSTULE WITH A SMALL QUANTITY OF BLOODY EXUDATE. THE PATIENT WAS TREATED INTRAPERITONEALLY WITH VANCOMYCIN (DOSAGE NOT REPORTED) EVERY FIVE DAYS AND TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE PATIENT WAS ALSO AWAITING CATHETER REMOVAL SURGERY AND SURGICAL CLEANING OF THE ABSCESS. AN ARTERIOVENOUS FISTULA WAS PUT IN PLACE TWO WEEKS PRIOR TO THIS REPORT. THE PATIENT WAS TO BE TRANSFERRED TO HEMODIALYSIS FOLLOWING THE SURGERY. THE CAUSE OF THE PERITONITIS REMAINS UNKNOWN AND THE CAUSE OF THE ABSCESS WAS NOT REPORTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS TREATED WITH VANCOMYCIN 2 GRAM(G), INTRAPERITONEAL INJECTION (IP), EVERY 5 DAYS) AND CEFTAZIDIME (IP, 1 G/DAY). PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291463 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention MEROPENEM, CEFTAZIDIME, PHYSIONEAL, AND EXTRANEAL