Flowonix Medical Inc recalls Prometra II Programmable Pump (Clinical), Cat. No. 01827 F

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Serial Numbers: 10ET4A02 36AR4A11 36AR4A33 36FR4A01 36HS4A25 36JN4A09 36JN4A30 36KN4A13 36KN4A33 10ET4A06 36AR4A12 36AR4A34 36FR4A08 36HS4A26 36JN4A10 36JN4A31 36KN4A15 36KN4A34 10ET4A07 36AR4A13 36AR4A35 36FR4A09 36HS4A27 36JN4A11 36JN4A32 36KN4A16 36KN4A35 10ET4A20 36AR4A14 36AR4A37 36FR4A12 36HS4A29 36JN4A12 36JN4A33 36KN4A17 36KN4A36 10ET4A21 36AR4A15 36BS4A08 36FR4A13 36HS4A34 36JN4A13 36JN4A35 36KN4A18 36KN4A38 10ET4A46 36AR4A16 36BS4A17 36FR4A16 36HS4A39 36JN4A14 36JN4A37 36KN4A19 36KN4A40 10IT4A16 36AR4A17 36BS4A18 36FR4A19 36HS4A42 36JN4A15 36JN4A39 36KN4A20 36KN4A41 10IT4A21 36AR4A18 36ES4A03 36FR4A22 36HS4A43 36JN4A16 36KN4A01 36KN4A21 36KN4A42 10IT4A22 36AR4A19 36ES4A07 36FR4A24 36HS4A46 36JN4A17 36KN4A02 36KN4A22 36KN4A43 36AR4A01 36AR4A20 36ES4A08 36HS4A01 36HS4A51 36JN4A18 36KN4A03 36KN4A23 36KN4A44 36AR4A02 36AR4A21 36ES4A14 36HS4A02 36HS4A53 36JN4A19 36KN4A04 36KN4A24 36KN4A45 36AR4A03 36AR4A22 36ES4A15 36HS4A04 36HS4A54 36JN4A21 36KN4A05 36KN4A25 36AR4A04 36AR4A23 36ES4A17 36HS4A07 36HS4A55 36JN4A22 36KN4A06 36KN4A26 36AR4A05 36AR4A24 36ES4A18 36HS4A10 36HS4A61 36JN4A23 36KN4A07 36KN4A27 36AR4A06 36AR4A27 36ES4A19 36HS4A14 36JN4A03 36JN4A25 36KN4A08 36KN4A28 36AR4A07 36AR4A29 36ES4A20 36HS4A20 36JN4A04 36JN4A26 36KN4A09 36KN4A29 36AR4A08 36AR4A30 36ES4A22 36HS4A21 36JN4A06 36JN4A27 36KN4A10 36KN4A30 36AR4A09 36AR4A31 36ES4A28 36HS4A22 36JN4A07 36JN4A28 36KN4A11 36KN4A31 36AR4A10 36AR4A32 36ES4A33 36HS4A23 36JN4A08 36JN4A29 36KN4A12 36KN4A32