BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN

    MDR report key: 951926 · Received November 19, 2007

    Report

    Report Number
    2031921-2007-00036
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Report Date
    October 5, 2007
    Manufacturer
    CURLIN MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON PHYSICAL INSPECTION OF THE DEVICE, IT WAS NOTICED THAT THE DOOR LATCH WAS DAMAGED INDICATING EVIDENCE THAT THE DEVICE WAS ABUSED (E.G. DROPPED). IT APPEARS THAT THE PUMP HAS BEEN DAMAGED BY A DROP IN A WAY THAT WOULD AFFECT THE PLATEN. THE PLATEN IS BENT ENOUGH TO NOT ALLOW THE PUMPING MECHANISM TO COMPRESS THE PUMPING CHAMBER. THIS COULD RESULT IN INACCURATE INFUSION (OVER OR UNDER DELIVERY DEPENDING ON HEAD HEIGHT OF MEDICATION RESERVOIR). FUNCTIONAL TESTING OF THE PUMP CONFIRMS THAT THE RETURNED UNIT DID NOT MEET SPECIFICATIONS AS A RESULT OF THE DAMAGE (I.E. THE TESTING INDICATED THAT THE PRODUCT OVER DELIVERED). CURLIN MEDICAL INC RECOMMENDS IN OUR USER MANUAL THAT THE PUMP BE CHECKED FOR DAMAGE IN-BETWEEN PT USE INCLUDING A VOLUMETRIC ACCURACY TEST. HAD THESE INSTRUCTIONS BEEN FOLLOWED, IT IS LIKELY THAT THIS MALFUNCTIONS WOULD HAVE BEEN DETECTED PRIOR TO PT USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CURLIN MEDICAL INFUSION PUMP ALLEGEDLY MALFUNCTIONED AND OVER INFUSED IN THE FIELD. THERE WAS NO PT INJURY REPORTED. THERE WAS NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN CURLIN MEDICAL INFUSION PUMP FRN CURLIN MEDICAL, INC. 4000 CMS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR