MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLUM 360 DRIVER REFURB; PUMP INFUSION

Model Number	30010
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date in 2018.The event involved a customer allegation the device turns off the moment it is unplugged, does not hold a charge.A review of the event log showed several recent entries for n56 replace battery and n252 depleted battery alarms.During testing and investigation, the device was powered up and displayed the battery depleted message with the battery icon empty.The device was connected to ac power and a message to keep the device plugged into ac power was displayed.The device passed a self-test on ac power.When disconnected from ac power, the device displayed a depleted battery message and powered off.The complaint was confirmed.A new battery was installed and the change battery option was keyed.The device then passed testing.The probable cause of a combination of a depleted battery and change battery option not keyed is related to a known software issue in version 15.02.00.008.Due to the software issue, when there is a replace battery condition and the device is disconnected from ac power, the "depleted battery" alarm occurs in place of the "replace battery" alarm and causes the pump to shut down after 3 minutes.

• Brand Name: PLUM 360 DRIVER REFURB
• Common Device Name: PUMP INFUSION
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia, ; CS
• MDR Report Key: 7918891
• Report Number: 9615050-2018-00059
• Device Sequence Number: 19169120
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: M3353001004051
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30010
• Device Catalogue Number: 30010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1682-2017
• Patient Sequence Number: 1