BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2091499 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06056
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE LOW DRAIN VOLUME ALARM WAS AIR IN PATIENT LINE. AS A SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THE COMPLAINT COULD NOT BE CONFIRMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE HOME PATIENT (HP) CONTACTED BAXTER AND REPORTED A LOW DRAIN VOLUME ALARM, WHICH OCCURRED ON THE HOMECHOICE UNIT DURING INITIAL DRAIN. ON (B)(6) 2011, BAXTER CONTACTED THE HP WHO REPORTED THERE WERE 1/2 INCH GAPS OF AIR ALL IN THE PATIENT LINE. THE HP STATED HE DID NOT CHECK TO SEE IF THERE WERE ANY LOOSE CONNECTIONS OR HOLES IN ANY OF THE SUPPLIES. THE HP WAS NOT ABLE TO DETERMINE HOW AIR ENTERED THE LINE. THE HP STATED HE WAS BEING RETRAINED ON THERAPY BY HIS PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) AS A RESULT OF THIS EVENT. THE HP STATED HE WAS PRESCRIBED MEDICATION AND HAD AN INFECTION. ON (B)(6) 2011 BAXTER SPOKE WITH THE PD RN WHO CONFIRMED IN (B)(6) 2011 THE HP EXPERIENCED PERITONITIS. THE HP WAS NOT HOSPITALIZED FOR THE EVENT; THE EFFLUENT CULTURE REVEALED BACTERIAL PERITONITIS. THE PD RN FURTHER STATED THE AIR IN LINE AND RESULTING PERITONITIS WAS RELATED TO THE PATIENT NOT PERFORMING THERAPY CORRECTLY AND NOT WEARING A MASK. THE PATIENT WAS RETRAINED ON PROPER THERAPY TECHNIQUES. IN (B)(6) 2011 THE PATIENT WAS TREATED WITH VANCOMYCIN 2GM/WEEK AND WAS TO RECEIVE TREATMENT FOR A TOTAL OF 4 DOSES. THE NURSE STATED THE EVENT OF PERITONITIS WAS RESOLVING AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention DIANEAL LOCAL (PD4) AMBUFLEX| HOMECHOICE