BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1943125 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07436
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 9, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR-POOR ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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 AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED.

    Description of Event or Problem · 1

    DURING A CALL FOR AN UNRELATED ISSUE, THE PATIENT INDICATED TO THE (B)(4) CALL CENTER STAFF THAT THE PATIENT HAD PERITONITIS. THIS IS A SPONTANEOUS CASE REPORT BY A PATIENT FROM (B)(6) OF PERITONITIS IN A PATIENT (AGE UNKNOWN) COINCIDENT WITH DIANEAL PD THERAPY. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL UNKNOWN THERAPY. ON (B)(6) 2010, THE PATIENT CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT HE WAS RECEIVING TREATMENT FOR MILD PERITONITIS. IT WAS NOT REPORTED IF HE WAS HOSPITALIZED OR NOT. THE OUTCOME OF THE EVENT AND THE CAUSALITY WERE NOT REPORTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. FOLLOW-UP INFORMATION RECEIVED FROM A PHYSICIAN ON (B)(4) 2010 IS AS FOLLOWS: IT WAS CLARIFIED THAT THE PATIENT IS MALE. THIS CASE IS LINKED TO (B)(4). ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD-2 2.5 THERAPY. ON (B)(6) 2010, HE DEVELOPED PERITONITIS AND WENT TO HOSPITAL. IT WAS UNKNOWN IF A PERITONEAL EFFLUENT ANALYSIS WAS PERFORMED. HE WAS TREATED WITH UNSPECIFIED ANTIBIOTICS AS AN OUTPATIENT. THE CAUSE OF THE PERITONITIS WAS THE PATIENT'S UNSTERILIZED TECHNIQUE. HE WAS RETRAINED OF ASEPTIC TECHNIQUE. DIANEAL N WAS REMAINED ONGOING. ON AN UNKNOWN DATE, HE WAS RECOVERING FROM THE EVENT. THE PHYSICIAN CONSIDERED THAT THE PERITONITIS WAS NON-SERIOUS AND NOT RELATED TO DIANEAL N THERAPY SINCE THE EVENT WAS CAUSED BY THE PATIENT'S UNSTERILIZED TECHNIQUE. NO FURTHER INFORMATION IS AVAILABLE.

    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 Required Intervention DIANEAL-N PD-2 2.5 THERAPY