MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLUM 360 DRIVER NEW

Model Number	30010
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date in 2018.The event involved the customer allegation the device was not functioning.During testing and investigation, the device displayed a depleted battery message with an empty battery icon, while powered up on battery.Additionally, while the device was on a/c power, a message appeared to keep the device plugged into a/c power.The device history logs identified multiple, n56 (replace battery) and n252 (depleted battery) alarms.The device passed a self-test on a/c.Testing determined the probable cause was the combination of a depleted battery and the change battery option was not keyed; therefore, the battery was replaced and the battery option keyed.The device passed all pvt testing.The complaint was confirmed and determined to be 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 NEW
• Common Device Name: PLUM 360 DRIVER NEW
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia, ; CS
• MDR Report Key: 7907163
• Report Number: 9615050-2018-00056
• Device Sequence Number: 19279293
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: M3353001004051
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/27/2018

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: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/25/2018
• 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