BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2152133 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08736
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    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). AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 (GD884460) 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

    A HOME PATIENT (HP) REPORTED TO BAXTER THAT HE WAS HOSPITALIZED FROM (B)(6) 2011- (B)(6) 2011 FOR PERITONITIS. THE HP STATED THAT ON A DATE IN (B)(6) 2011 SYMPTOMS STARTED AFTER A HOSPITAL RN REUSED A MINICAP. ON (B)(6) 2011, BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) WHO STATED THAT SHE BELIEVED CAUSALITY OF THE PERITONITIS WAS DUE TO AN EXIT SITE INFECTION THAT WAS DIAGNOSED ON (B)(6) 2011, TRAVELLING INTO THE PERITONEUM AND THAT THE HP WAS RECOVERING AT THE TIME OF THIS REPORT. HOSPITAL TREATMENT INFORMATION WAS NOT AVAILABLE. TREATMENT IN (B)(6) 2011 WAS WITH ORAL (PO) LEVAQUIN 250MG ONCE DAILY FOR 10 DAYS.

    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 56 YR Hospitalization| R LOCAL (PD4) ULTRABAG