BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2103840 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06566
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 3 FOR THIS INCIDENT OF PERITONITIS. FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBER (GD882639) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) ON (B)(4) 2011 REGARDING THE REPORT OF PATIENT HOSPITALIZATION. THE RN STATED THAT THE HOME PATIENT (HP) WAS HOSPITALIZED FOR PERITONITIS BUT WAS CONTINUING THERAPY ON THE CYCLER. THE RN STATED SHE WAS WILLING TO BE CONTACTED FOR ADDITIONAL INFORMATION. BAXTER RECEIVED A PHONE CALL FROM THE PDRN ON (B)(6) 2011. SHE REPORTED THE PATIENT WAS HOSPITALIZED FOR PERITONITIS FROM (B)(6) 2011. THE PATIENT WAS USING DIANEAL LOCAL (PD4) AMBUFLEX. SHE REPORTED THAT ON AN UNKNOWN DATE PD CULTURES, CELL COUNT AND GRAM STAINS WERE DONE. THE PATIENT STARTED TREATMENT ON AN UNKNOWN DATE. TREATMENT INCLUDES UNKNOWN DOSES OF VANCOMYCIN AND FORTAZ. TREATMENT WAS TO BE COMPLETED ON (B)(6) 2011. THE PATIENT'S CONDITION HAD IMPROVED. THERE WAS NO EXIT SITE INFECTION. THE PATIENT CONTINUED PD THERAPY WITHOUT DIFFICULTY. THERE WAS NO ALLEGATION AGAINST ANY BAXTER DEVICE OR SOLUTION. NO FURTHER INFORMATION WAS AVAILABLE.

    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 28 YR Hospitalization| R DIANEAL LOCAL (PD4) AMBUFLEX| HOME CHOICE