BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1943064 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06476
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED, BECAUSE NEITHER A SAMPLE OR LOT NUMBER WERE PROVIDED BY THE CUSTOMER. 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). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER OF AN OF UNKNOWN CLEARLINK SET(S), IN WHICH A NO FLOW WAS DETECTED DURING PATIENT USE ON AN UNKNOWN DATE. THE HOSPITAL HAD JUST CONVERTED FROM THE HOSPIRA CLAVE TUBING TO BAXTER CLEARLINK TUBING WITH THEIR UPGRADE FROM HOSPIRA CALIBRATED SIGMA PUMPS TO THE BAXTER CALIBRATED SIGMA SOFTWARE 6.05. WHEN THEY INITIATED THE INFUSION, THEY USED AN UNKNOWN PHASEAL PRODUCT TO HELP MINIMIZE VAPORS/LEAKING OF CHEMOTHERAPY AGENT. WHEN THE TUBING WAS CONNECTED TO THE PATIENT, THE PUMP BEGAN TO BEEP DOWNSTREAM OCCLUSION. THE CHEMOTHERAPY WAS NOT INFUSING. THE PATIENT WAS STUCK TWO MORE TIMES BECAUSE THE CLINICIAN THOUGHT THE PROBLEM WAS THE IV LINE. THE CLINICIAN CHANGED THE PHASEAL, LOOSENING IT, AND THE INFUSION WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT. PER THE HOSPITAL REPORTER, THIS PROBLEM DID NOT OCCUR PRIOR TO THE CONVERSION TO THE BAXTER CLEARLINK AND THE BAXTER CALIBRATED SIGMA PUMP. NO INJURY OR MEDICAL INTERVENTION WAS NECESSARY. THE SIGMA PUMP SERIAL NUMBER IS UNKNOWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 SIGMA PUMP, UNKNOWN PHASEAL PRODUCT