BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2565251 · Received May 8, 2012

    Report

    Report Number
    1423500-2012-10424
    Event Type
    Injury
    Date Received
    May 8, 2012
    Date of Event
    April 1, 2012
    Report Date
    April 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS - NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE NO SAMPLE WAS RETURNED TO BAXTER AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR GD891325 AND GD891721 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS REQUESTED, BUT THE SAMPLE WAS DISCARDED. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(4) 2012, PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) REGARDING AN UNRELATED ALARM. DURING THE CONVERSATION, THE HP REPORTED DISCOMFORT DURING DRAIN WHICH HER NURSE WAS AWARE OF. THE HP ALSO REPORTED HAVING AN INFECTION THEY THAT MAY BE PERITONITIS BUT SHE WAS NOT SURE. ON (B)(4) 2012, GPV CONDUCTED FOLLOW-UP WITH THE PATIENT AND THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REGARDING THE REPORTED EVENTS. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE PATIENT: ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL DISCOMFORT, FEVER OF 100 DEGREES FAHRENHEIT AND CLOUDY PD EFFLUENT. IN (B)(6) 2012, A PD EFFLUENT SAMPLE WAS ANALYZED AND INTRAPERITONEAL (IP) ANTIBIOTIC THERAPY WAS INITIATED (TYPE, DOSE AND FREQUENCY UNKNOWN). AT THE TIME OF THIS REPORT, THE EVENTS OF ABDOMINAL DISCOMFORT, FEVER OF 100 DEGREES FAHRENHEIT AND CLOUDY PD EFFLUENT WERE ONGOING AND IMPROVED. THE PATIENT REMAINED ON PD THERAPY. PER THE PATIENT, THE EVENTS OF ABDOMINAL DISCOMFORT, FEVER OF 100 DEGREES FAHRENHEIT, AND CLOUDY PD EFFLUENT WERE NOT RELATED TO ANY BAXTER PRODUCTS. THE CAUSE OF CLOUDY PD EFFLUENT WAS UNKNOWN, BUT RETRAINING WAS PERFORMED. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE PDRN: IN (B)(6) 2012, THE PD EFFLUENT SAMPLE WAS ANALYZED AT THE CLINIC AND INTRAPERITONEAL (IP) VANCOMYCIN 2 GM Q 5 DAYS WAS INITIATED ON THE SAME DAY. AT THE TIME OF THIS REPORT, THE EVENTS OF ABDOMINAL DISCOMFORT, FEVER OF 100 DEGREES FAHRENHEIT, AND CLOUDY PD EFFLUENT WERE ONGOING AND IMPROVED. THE PATIENT REMAINED ON PD THERAPY. PER THE NURSE, THE EVENTS OF ABDOMINAL DISCOMFORT, FEVER OF 100 DEGREES FAHRENHEIT, AND CLOUDY PD EFFLUENT WERE NOT RELATED TO ANY BAXTER PRODUCTS. THE CAUSE OF CLOUDY PD EFFLUENT WAS UNKNOWN, BUT RETRAINING WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention DIANEAL PD4 ULTRABAG| HOMECHOICE| DIANEAL PD4 AMBUFLEX