BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2891063 · Received November 14, 2012

    Report

    Report Number
    2016493-2012-00496
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    November 2, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BIOMED INDICATED THAT HE WILL PERFORM HIS OWN INTERNAL INVESTIGATION AND WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE CAUSE OF THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A BIOMED CALLED TO DETERMINE HOW TO DOWNLOAD EVENT LOGS. HE REPORTED THAT THE IV DEVICE DELIVERED MEDICATION (UNSPECIFIED) TOO FAST AND THAT THE BAG WAS EMPTY TOO SOON. HE DID NOT KNOW IF THE MEDICATION WAS RUNNING AS A PRIMARY OR SECONDARY. THE REPORTER WOULD NOT PROVIDE NURSING CONTACT INFORMATION. IT WAS REPORTED THAT NO PATIENT HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER STATED THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE. HE ALSO STATED THAT HE WILL DO HIS OWN EVENT LOG REVIEW AND THAT NO PRODUCT WILL BE SENT IN FOR AN INVESTIGATION. NO TUBING WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMINISTRATION SETS| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| MODELS/LOT NUMBERS UNK| ALARIS PC UNIT, SN (B)(4)