BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2656163 · Received July 16, 2012

    Report

    Report Number
    1423500-2012-14171
    Event Type
    Injury
    Date Received
    July 16, 2012
    Date of Event
    June 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK DURING THE DRAIN STAGE IS CONFIRMED BECAUSE THE HOME PATIENT STATED HE DISCOVERED THE FLOOR WAS WET AND HIS CAT CHEWING ON THE PATIENT LINE, WHICH IS A USE ERROR THAT WILL CAUSE A LEAK TO THE PATIENT LINE AND MAY LEAD TO CONTAMINATION. A LABELING REVIEW WAS COMPLETED AND DETERMINED THAT THE INSTRUCTIONS PROVIDE SUFFICIENT LEVEL OF DETAIL ON PREVENTING USE ERROR - BREACH IN ASEPTIC TECHNIQUE.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH (B)(6), IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON (B)(6) 2012, THE PATIENT CONTACTED BAXTER'S 24 HOUR HELPLINE REGARDING AN UNRELATED ISSUE. THE PATIENT CHECKED THE LINE AND OBSERVED THAT HIS CAT HAD BITTEN THROUGH THE LINES. HE WAS ADVISED BY THE HELPLINE REPRESENTATIVE TO CHANGE THE SUPPLIES. ON THE (B)(6) 2012, THE PATIENT PRESENTED HIMSELF TO THE PD UNIT WITH SEVERE BACTERIAL PERITONITIS. ADDITIONAL INFORMATION WAS RECEIVED BY THE NURSE, WHICH MEDICALLY CONFIRMED THE CASE. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE THE PATIENT'S CONTAMINATION DUE TO THE CAT BITING THE PD CATHETER LINE. ON (B)(6) 2012, THE PATIENT WAS TREATED WITH VANCOMYCIN (2.9G X2 DOSES). ON (B)(6) 2012, VANCOMYCIN WAS DISCONTINUED. ON (B)(6) 2012, THE PATIENT RECOVERED FROM THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(6) REGARDING A LEAK FROM A CASSETTE. THE HOME PATIENT (HP) WAS CONNECTED TO THE MACHINE WHEN THEY RECEIVED A LOW DRAIN VOLUME ALARM, DURING DRAIN 2. THE DRAIN VOLUME (DV) WAS 7ML. THE HP STATED THERE WAS ABOUT 2 LITERS OF FLUID ON THE FLOOR. THE HP WOKE UP DUE TO THE HC SAYING LDV AND DISCOVERED THE FLOOR WAS WET AND HIS CAT CHEWING ON THE PATIENT LINE. TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO END THE THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR ASSISTED THE HP TO END THERAPY. CALL COMPLETED. HP WILL START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DIANEAL PD4 AMBUFLEX