BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUIPO CASETTE PARA APD

    MDR report key: 1932451 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07026
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION SAMPLE IS INDICATED TO BE AVAILABLE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED AND/OR UPON COMPLETION OF BAXTER'S INVESTIGATION. A 510(K) NUMBER WILL NOT BE PROVIDED AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: TWO COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. NO DEFECT WAS EVIDENCED DURING VISUAL AND LEAK TESTS PERFORMED ON THE SAMPLES. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION OF PERITONITIS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A TREND REVIEW WAS PERFORMED FINDING THAT NO REPORTS RELATED TO PERITONITIS HAVE BEEN RECEIVED INVOLVING THE LOT REPORTED FOR THIS EVENT.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) CUSTOMER SERVICE AND REPORTED THAT A PATIENT WAS NORMALLY PERFORMING DIALYSIS ON (B)(6) 2010 BUT DURING THE NIGHT SHE OBSERVED THAT SHE WAS WET. WHEN THE PATIENT WAS INVESTIGATING WHY SHE WAS WET, SHE DETECTED A LEAK ON THE CASSETTE LINE. THE PATIENT EXPERIENCED ABDOMINAL PAIN DURING THE WEEKEND BUT SHE DID NOT GO TO THE HOSPITAL. ON (B)(6) 2010, THE PATIENT WENT TO THE HOSPITAL WHERE IT WAS DETECTED THAT THERE WAS REALLY A LEAK ON THE CASSETTE LINE. PERITONEAL EFFLUENT WAS COLLECTED. THE EFFLUENT WAS TURBID AND HAD A POSITIVE CULTURE. THE PATIENT PRESENTED WITH PERITONITIS ONE WEEK AFTER THE LEAK WAS OBSERVED; HOWEVER, THE PATIENT RESPONDED WELL TO ANTIBIOTIC TREATMENT AND SHE HAS ALREADY RETURNED TO HER HOUSE. THE CASSETTE THAT PRESENTED THE LEAK WAS DISCARDED. THE PATIENT INDICATED THAT SHE TOOK AN ANTIBIOTIC FOR 10 DAYS AND NOW SHE IS WELL. THE PATIENT INDICATED THAT SHE OBSERVED THE LEAK BETWEEN THE CASSETTE AND THE TUBE DUE TO A CUT. THE PATIENT USED ALL THE UNITS OF THIS LOT AND SHE HAS ONLY 01 COMPANION SAMPLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ON (B)(6) 2011 FROM A PERITONEAL DIALYSIS NURSE: THE PATIENT PERFORMS AUTOMATED PERITONEAL DIALYSIS (APD). THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. THERE WAS AN EXIT SITE/TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. THE NURSE INDICATED HER OPINION OF CAUSALITY WAS THE LEAK ON THE HC CASSETTE DISPOSABLE. THE NURSE INDICATED THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUIPO CASETTE PARA APD SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - CALI SX10CR9

    Patients

    Seq Age Sex Outcome Treatment
    1