BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0707 TINA SINGLE PUMP NIBPLCD

    MDR report key: 1848771 · Received September 30, 2010

    Report

    Report Number
    1423500-2010-03908
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - MIAMI LAKES
    Product Code
    KDI
    PMA / PMN Number
    K970446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE FACILITY'S BIOMEDICAL TECHNICIAN RESOLVED THE PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW INDICATED THAT THE DEVICE WAS LAST SERVICED BY BAXTER ON 08/24/2010 FOR DEVICE WILL NOT HEAT DISINFECT. THE BLEACH CONNECTOR WAS REPLACED. THE MACHINE WAS TESTED ACCORDING TO THE SYSTEM 1000 FUNCTIONAL DATA. NO OTHER PROBLEMS WERE NOTED. THE INSTRUMENT MET ALL FUNCTIONAL SPECIFICATIONS, WAS OPERATIONAL AND WAS READY FOR USE. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM OF LEAK IN THE MACHINE. THE DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR ANY ISSUES RELATED TO THE REPORTED PROBLEM. THE REPORTED ISSUE WAS CONFIRMED BY THE CUSTOMER'S BIOMEDICAL TECHNICIAN. THE CUSTOMER'S BIOMEDICAL TECHNICIAN INDICATED THAT THE INTERNAL TUBING OF THE TINA MACHINE CAME OFF OF THE CONNECTOR. THE BIOMED TECH PUT THE TUBING BACK ONTO THE CONNECTOR AND WAS ABLE TO CONTINUE WITH THE SETUP WITHOUT ANY FURTHER PROBLEMS. BASED ON THE BIOMEDICAL TECHNICIAN'S FINDINGS, THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE WAS DUE TO INTERNAL TUBING OF THE TINA MACHINE CAME OFF OF THE CONNECTOR. 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.

    Description of Event or Problem · 1

    A BIOMED TECHNICIAN (BT) CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A TINA HEMODIALYSIS INSTRUMENT THAT HAD A LEAK WHICH OCCURRED DURING PROGRAMMING/SETUP. THE BT NEEDED INFORMATION ON HOW TO OPEN THE DOOR TO CHECK THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FIELD SERVICE ENGINEER (FSE) RESPONDED TO THE CALL AND SPOKE WITH THE BT WHO STATED HE WANTED TO KNOW HOW TO OPEN THE HEMODIALYSIS MACHINE TO CHECK THE TUBING, DUE TO A LEAK IN THE MACHINE. (B)(4). THE BT INDICATED THAT HE WOULD DO THAT. THE FACILITY'S BT WAS CONTACTED ON (B)(4) 2010. THE BT INDICATED THAT THE INTERNAL TUBING OF THE TINA MACHINE CAME OFF OF THE CONNECTOR. THE BT JUST PUT THE TUBING BACK ONTO THE CONNECTOR AND WAS ABLE TO CONTINUE WITH THE SETUP WITHOUT ANY FURTHER PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0707 TINA SINGLE PUMP NIBPLCD DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MIAMI LAKES

    Patients

    Seq Age Sex Outcome Treatment
    1