BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3182956 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16182
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: NEW INFORMATION RECEIVED CLARIFIED THE PREVIOUSLY REPORTED EVENT OF PATIENT (PT) DISCHARGED FROM THE HOSPITAL TO A REHABILITATION FACILITY DUE TO LOSS OF STRENGTH WAS UNRELATED TO THE PERITONITIS EVENT. PER THE PD NURSE (PDN), THE LOSS OF STRENGTH WAS RELATED TO THE PATIENT'S OTHER CO-MORBIDITIES (UNSPECIFIED). THE PDN STATED, THE CAUSE OF THE PERITONITIS WAS DUE TO A BOWEL OBSTRUCTION THAT CAUSED BOWEL CONTENTS TO SEEP INTO THE PERITONEUM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBERS H12I27059, H11J24049 AND H12L07031 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: TWENTY DAYS AFTER BEING HOSPITALIZED FOR THE PERITONITIS, THE PT WAS DISCHARGED FROM THE HOSPITAL TO A REHABILITATION FACILITY DUE TO "LOSS OF STRENGTH" (DETAILS NOT PROVIDED). AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE "LOSS OF STRENGTH" AND DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND WAS ADMITTED TO HOSPITAL THE SAME DAY. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282788 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization HOMECHOICE, DIANEAL PD4 AMBUFLEX,| DIANEAL PD4 ULTRABAG AND EXTRANEAL VIAFLEX