BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3841558 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17482
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWENTY DAYS AFTER NOTICING A HOLE IN THE PERITONEAL DIALYSIS (PD) CATHETER, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT¿S PD CATHETER WAS REPAIRED. ON THE DAY OF ONSET OF PERITONITIS, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DISCHARGED 6 DAYS LATER. BEGINNING ON THE DAY OF HOSPITALIZATION, THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAPERITONEALLY (IP) (DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) AND GENTAMYCIN IP FOR 21 DAYS (DOSAGE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS EVENT. IT WAS UNKNOWN WHEN VANCOMYCIN THERAPY COMPLETED. FOUR DAYS AFTER BEING DISCHARGED, THE PATIENT WAS READMITTED TO THE HOSPITAL. THE DAY FOLLOWING THE SECOND HOSPITAL ADMISSION, THE PATIENTS¿ PD CATHETER WAS REMOVED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. PD THERAPIES WERE NOT ONGOING. THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H14A07064 WAS PERFORMED 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. AS THE SAMPLE WAS NOT RETURNED A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE NURSE STATED THAT THE PT HAD EXPERIENCED A HOLE IN THEIR PD CATHETER 2 WEEKS PRIOR TO THE EVENT, BUT DUE TO THE DATES THEY ARE UNABLE TO BE SURE THAT IT WAS THE CAUSE OF THE EVENT. THE SAME DAY AS THE ONSET OF THE EVENT, THE PT WAS HOSPITALIZED . ON AN UNREPORTED DATE, THE PT WAS TREATED WITH VANCOMYCIN IP FOR PERITONITIS. FOUR DAYS AFTER ADMISSION TO THE HOSPITAL, THE PT WAS DISCHARGED. FIVE TO SIX DAYS LATER, THE PT PRESENTED TO THE CLINIC WITH CLOUDY EFFLUENT AND WAS RE-ADMITTED TO THE HOSPITAL. TREATMENT FOR THAT EVENT WAS UNKNOWN, BUT THE PT DID HAVE THE PD CATHETER REMOVED. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING AND TREATMENT FROM THE FIRST PERITONITIS EVENT WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317933 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R EXTRANEAL, MINICAP, CASSETTE| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE| DIANEAL| HOMECHOICE, DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX| MINICAP