BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1862645 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04241
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A CONNECTION ISSUE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE DUE TO ONE OF THE SUPPLY BAGS FALLING AND DISCONNECTING. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED SHE WAS RE-STARTING THERAPY WITH NEW SUPPLIES WHEN HER HUSBAND DIDN'T TIGHTEN THE CONNECTION BETWEEN THE SOLUTION BAG AND PATIENT LINE COMPLETELY SO THE BAG FELL AND DISCONNECTED. THE HP WAS NOT CONNECTED AT THE TIME OF THE SEPARATION AS IT WAS DURING SETUP. THE HP STATED SUPPLIES WERE DISCARDED AND REMAINING PRODUCT HAS BEEN ALL USED UP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A BAG THAT BECAME DISCONNECTED ON THE HOMECHOICE (HC) MACHINE DURING SET UP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO RESTART SETUP WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    BAXTER (B)(4) FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE INFUSION PUMP FOR A BATTERY ISSUE ON (B)(6) 2010. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING BAXTER'S REVIEW OF THE EVENT HISTORY ON (B)(6) 2010 IT WAS DISCOVERED THAT A BATTERY DEPLETED ALARM OCCURRED DURING INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY ON (B)(6) 2010. THE DEVICE HAS BEEN EVALUATED ONSITE. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER HOMECARE NURSE FROM (B)(6) FOR GASTROENTERITIS, DIARRHEA, AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO UNSPECIFIED SYMPTOMS. ON (B)(6) 2010, DURING HOSPITALIZATION, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND DIARRHEA. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL TREATMENT PER HOSPITAL PROTOCOL WITH CEFAZOLINE (125MG/L DAILY IP) AND CEFTAZIDIME (125MG/L DAILY IP). REMEDIAL TREATMENT WITH CEFAZOLINE AND CEFTAZIDIME WERE ONGOING. FOLLOW-UP INFORMATION WAS RECEIVED FROM THE NURSE ON (B)(6) 2010. ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED GASTROENTERITIS WITH VOMITING. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 FOR GASTROENTERITIS, PREVIOUSLY REPORTED AS UNSPECIFIED SYMPTOMS. ON (B)(6) 2010, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. ANTIBIOTIC AND PD THERAPY WAS ONGOING AND NO CHANGE IN TECHNIQUE WAS PRESCRIBED. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE GASTROENTERITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR