FDA recall Z-1716-2019

Product

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

Reason for recall

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.

Distribution

US nationwide distribution.

Key facts

Status

Terminated

Initiation date

2019-03-21

Report date

2019-06-12

Termination date

2020-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1716-2019