BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2080141 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05575
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD879924 WHICH REVEALED VOIDS WERE NOTED IN THE POUCH SEAL DURING MANUFACTURING. CORRECTIVE ACTIONS WERE IMPLEMENTED BY THE MANUFACTURING FACILITY AND A RE-INSPECTION OF THE LOT WAS PERFORMED WHICH REVEALED ALL AFFECTED UNITS WERE REMOVED PRIOR TO RELEASE OF THE LOT. THE ROOT CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS (STAPH) IN A PATIENT (AGE UNREPORTED) COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. TREATMENT INFORMATION WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. DIANEAL THERAPY WAS ONGOING. UPON A FOLLOW-UP CALL TO THE PATIENT'S NURSE, THE NURSE REPORTED THAT THE PATIENT DID NOT HAVE PERITONITIS. THE NURSE DECLINED FURTHER INFORMATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT PROVIDED.

    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 61 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE