BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP

    MDR report key: 2822601 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04284
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE SAMPLE WILL NOT BE PROVIDED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CUSTOMER REPORTED PROBLEM WAS NOT CONFIRMED IN SERVICE BECAUSE THE PUMP WAS NOT SENT IN FOR EVALUATION. THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND.

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE CONTACTED A BAXTER SALES REPRESENTATIVE TO REPORT AN I-PUMP THAT WAS EXPERIENCING ACCURACY PROBLEMS. ACCORDING TO THE REPORT, BAGS WERE USED WITH THE I-PUMP AND 18-25ML OF FLUID WAS OBSERVED TO BE REMAINING IN THE BAGS (100ML EXPECTED DELIVERY). THE FACILITY REPRESENTATIVE LATER CONTACTED BAXTER TO INFORM THEM THAT THE SETTINGS ON THIS PUMP WERE SET TO THE FACTORY DEFAULT. WHEN CHANGED TO THE APPROPRIATE SETTING, THE PUMPS FUNCTIONED CORRECTLY. THE DRUG CONCENTRATION BEING INFUSED AT THE TIME WAS FENTANYL CITRATE 2MCG/ML AND 0.125% BUPIVACAINE HCL IN 0.9% SODIUM CHLORIDE 100ML VOLUME NDC# 61553-0125-48. IT WAS NOTED THAT A PATIENT EXPERIENCED A LACK OF EFFECT FROM THE DRUG ADMINISTERED DURING INFUSION FROM THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PUPM, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 0.125% BUPIVACAINE HCL| 0.9% SODIUM CHLORIDE 100ML| FENTANYL CITRATE 2MCG/ML