BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2223497 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11252
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10K29039, H11A03058, H11D12038, H11G12049 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    INITIALLY THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME CHOICE (HC), LOW DRAIN VOLUME ALARM, WHICH OCCURRED DURING THERAPY DURING THE INITIAL DRAIN. THE PERITONEAL DIALYSIS NURSE (PDN) CLEARED THE ALARM AND THE DRAIN WAS COMPLETED THEREFORE, NO TROUBLESHOOTING WAS REQUIRED. THERE WAS NO REPORT OF PATIENT INJURY OR NEED FOR MEDICAL INTERVENTION AT THE TIME OF THE INITIAL CALL. ON (B)(6) 2011 BAXTER PRODUCT SURVEILLANCE (PS) CONTACTED THE PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE LOW DRAIN VOLUME ALARM AND A REPORT OF PATIENT HOSPITALIZATION. PER THE PDN, THE HP WAS HAVING ABDOMINAL PAIN AND WENT IN THE HOSPITAL FOR PERITONITIS. NO FURTHER INFORMATION WAS GIVEN AT THE TIME OF THIS FOLLOW UP CALL. ON (B)(6) 2011, PS CONTACTED THE PDN TO FOLLOW UP ON THE REPORT OF PERITONITIS. THE FOLLOWING INFORMATION WAS RECEIVED. ON AN UNSPECIFIED DATE IN (B)(6) 2011 THE PATIENT (AGE NOT REPORTED) WAS DIAGNOSED WITH BACTERIAL PERITONITIS. THE PDN REPORTED THAT ON AN UNSPECIFIED DATE, THE HOME PATIENT (HP) WAS EXPERIENCING ABDOMINAL PAIN AND WENT TO THE HOSPITAL IN THE NIGHT. THE HP WAS HOSPITALIZED ON (B)(6) 2011 AND WAS DISCHARGED ON (B)(6) 2011. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE, FREQUENCY, ROUTE, NOT REPORTED). THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE EVENT . DIANEAL LOCAL 2.5% THERAPY WAS ONGOING. ON AN UNREPORTED DATE, THE PATIENT RECOVERED. THE PDN STATED THE CAUSE WAS PROBABLY DUE TO A BREAK IN ASEPTIC TECHNIQUE. IT WAS NOT REPORTED IF RETRAINING IN ASEPTIC TECHNIQUE WAS DONE. THE PDN DECLINED TO PROVIDE ANY CONCOMITANT MEDICATIONS. THE PDN STATED THAT SHE DID NOT BELIEVE THE CAUSE OF THE PERITONITIS WAS RELATED TO A BAXTER DEVICE OR SOLUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R DIANEAL LOCAL (B)(4)