BEUDAMED
    FDA Recall Terminated

    Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.

    Recall: Z-1716-2019 · Initiated March 21, 2019

    Recall

    Recall Number
    Z-1716-2019
    Event Number
    82586
    Firm
    Flowonix Medical Inc
    FEI Number
    3010079947
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    March 21, 2019
    Terminated
    June 5, 2020
    Address
    120 Forbes Blvd, Ste 170, Mansfield, MA, 02048-1150

    Description

    Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.

    Reason

    The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.

    Action

    On March 21, 2019, the firm issued Urgent Recall Notices to customers to inform them of the product issue. In May 2019, the firm sent updated communications to customers: Healthcare providers who have Clinician Programmers with SW 2.00.29 were sent a follow-up recall letter. This letter included the information that the pump stop following "Error Code 115" will only occur after the Bridge or Demand Bolus is complete, which could take up to seventy-two (72 hours). In addition, in the event of any cause of an "Error Code 115", the pump sounds a one-beep alarm and then shuts down. This behavior differs from the Instructions for Use, which state that the pump will sound three long (half second) beeps every 30 minutes for all critical errors. As it is unlikely that the patient will notice the single beep, there may be a significant delay in the patient becoming aware that the pump has stopped delivering therapy which may in turn delay resumption of drug therapy. Healthcare providers who have Clinician Programmers with any other version of the software and the implant pumps received a Corrective Action Notice. This notice included the information from the preceding paragraph, noting the discrepant alarm behavior for "Error Code 115" could be missed by the patient. Customers with the new Prometra Clinician Programmer software (v. 2.00.29) were asked to do the following: 1. STOP using the Periodic Flow or Multiple Rates flow mode functions in combination with a Bridge or Demand Bolus using the Clinician Programmer with Software Version 2.00.29. The error only occurs when these functions are used together. a. In the event that a Bridge or Demand Bolus is needed, convert the patient to Constant Flow Mode, then program the Bridge or Demand Bolus as needed (instructions for use PL-11803-04, page 30). Once the bolus is complete, revisit the patient or have him/her return to your clinic for programming back into their original flow mode. 2. IDENTIFY

    Distribution

    US nationwide distribution.

    Quantity

    163