BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2090347 · Received May 16, 2011

    Report

    Report Number
    1423500-2011-06035
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD882647 AND GD881565 WITH NO DEFECTS NOTED. 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 CAUSE OF THE PERITONITIS WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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 WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS IN A PATIENT (AGE NOT REPORTED) COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT WAS TAKING ANTIBIOTICS FOR AN UNKNOWN CAUSE (TYPE OF ANTIBIOTIC UNSPECIFIED) AND DEVELOPED PERITONITIS. THE NURSE REPORTED THE FOLLOWING INFORMATION. ON AND UNKNOWN DATE, THE PATIENT MADE A MISTAKE AND EXPERIENCED TOUCH CONTAMINATION AND DEVELOPED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT PROVIDED WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME FOR THE PATIENT MADE A MISTAKE AND TOUCH CONTAMINATION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS WAS UNRELATED TO DIANEAL THERAPY. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION.

    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 62 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX