Plum 1968528

• FDA 510(k) K141789 decided 16 Jan 2015 Active
• FDA GUDID UDI-DI 10887787008897 listed 1 Sep 2016 Listed

• • Ongoing Z-3162-2026 FDA Class II ·initiated 12 May 2026 ·on shared 510(k) K141789

  Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

• 2 recalls, same reason

  • Ongoing Z-2447-2024 FDA Class I ·initiated 7 May 2024 ·on shared 510(k) K141789
  • Ongoing Z-1565-2023 FDA Class I ·initiated 22 Mar 2023 ·on shared 510(k) K141789

  Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

• • Ongoing Z-2430-2023 FDA Class II ·initiated 13 Jul 2023 ·on shared 510(k) K141789

  Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.

• 3 recalls, same reason

  • Terminated Z-0127-2020 FDA Class II ·initiated 29 Jul 2019 ·on shared 510(k) K141789
  • Terminated Z-0128-2020 FDA Class II ·initiated 29 Jul 2019 ·on shared 510(k) K141789
  • Terminated Z-0145-2020 FDA Class II ·initiated 29 Jul 2019 ·on shared 510(k) K141789

  Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

• • Terminated Z-3031-2017 FDA Class II ·initiated 15 Jun 2017 ·on shared 510(k) K141789

  Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.

• • Terminated Z-1682-2017 FDA Class II ·initiated 30 Dec 2016 ·on shared 510(k) K141789

  Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.

• 2 recalls, same reason

  • Terminated Z-1832-2016 FDA Class II ·initiated 25 Mar 2016 ·on shared 510(k) K141789
  • Terminated Z-1833-2016 FDA Class II ·initiated 25 Mar 2016 ·on shared 510(k) K141789

  Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 1 Sep 2016 Listed FDA GUDID 10887787008897
2. 30 Dec 2016 Recall initiated FDA recalls Z-1682-2017
3. 15 Jun 2017 Recall initiated FDA recalls Z-3031-2017
4. 29 Jul 2019 Recall initiated FDA recalls Z-0127-2020
5. 29 Jul 2019 Recall initiated FDA recalls Z-0128-2020
6. 29 Jul 2019 Recall initiated FDA recalls Z-0145-2020
7. 22 Mar 2023 Recall initiated FDA recalls Z-1565-2023
8. 13 Jul 2023 Recall initiated FDA recalls Z-2430-2023
9. 7 May 2024 Recall initiated FDA recalls Z-2447-2024
10. 12 May 2026 Recall initiated FDA recalls Z-3162-2026

3 earlier events are in the sections above.

Trade name

Plum

Generic name

Bedside infusion pump, single-channel

Model / Ref / Catalog

1968528

Primary DI / UDI-DI

10887787008897

510(k) Number

K141789 ↗

FDA product code

FPA

GMDN term

Bedside infusion pump, single-channel

Device class

Class II

Regulation number

880.5440

GUDID distribution status

In Commercial Distribution

Size

Length — 136 Inch

Category: Bedside infusion pump, single-channel

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