BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2082470 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05661
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 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
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION. 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). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT H10L09062, H11A25101, H11A23049 AND H11C10018 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. PER THE COMPLAINT INFORMATION, THE PATIENT STATED THERE WAS AIR IN THE LINE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF A SAMPLE. ROOT CAUSE WAS UNDETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A BAXTER CLINICIAN CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) REGARDING A RELATED REPORT OF THE HP HOSPITALIZED FOR PERITONITIS AFTER A REPORT OF AIR IN THE PATIENT LINE ON (B)(6) 2011. THE PDRN STATED THAT THE HP HAD REPORTED TO THE NURSE ON CALL THE AIR IN LINE ON (B)(6) 2011. THE FOLLOWING EVENING, THE HP REPORTED CLOUDY EFFLUENT WITH ABDOMINAL PAIN. THE HP WAS DIRECTED TO THE EMERGENCY ROOM FOR TREATMENT. PERITONEAL DIALYSIS (PD) EFFLUENT WAS OBTAINED. TREATMENT INITIATED IN THE HOSPITAL ON (B)(6) 2011 WAS INTRAPERITONEAL (IP) VANCOMYCIN 60MG EVERY 2 DAYS WITH IP FORTAZ 1GM DAILY, WHICH AFTER THE HP'S DISCHARGE ON (B)(6) 2011 FOR 5 MORE DAYS. LEVAQUIN 250 MG BY MOUTH DAILY FOR 5 DAYS WAS THEN INITIATED UNTIL (B)(6) 2011. THE PDRN STATED THAT SHE COULD NOT GIVE CAUSALITY FOR CERTAIN, BUT THAT SHE AND HP BELIEVED THE INCIDENT OF AIR IN THE LINE WAS AT THE ROOT OF THE EVENT. THE HP'S RECOVERY IS ONGOING AND IMPROVED WITH THE NEXT PD CLINIC APPOINTMENT SCHEDULED FOR (B)(6) 2011.

    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 35 YR Hospitalization| R HOMECHOICE| LOWCAL(PD4) AMBUFLEX| LOWCAL(PD4) ULTRABAG