BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3841561 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17483
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896290 AND GD896415 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. BEGINNING ON THE DAY OF ONSET, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN (DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) AND GENTAMYCIN IP (DOSAGE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS. GENTAMYCIN THERAPY LASTED FOR 21 DAYS. AFTER 6 DAYS OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED. PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING DURING THE HOSPITALIZATION. TEN DAYS AFTER THE ONSET, THE PATIENT WAS READMITTED TO THE HOSPITAL. THE FOLLOWING DAY, THE PATIENTS' PD CATHETER WAS REMOVED AND THE PATIENT WAS STARTED ON HEMODIALYSIS. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. 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).

    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 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317979 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

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