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

Catalog Number	30010
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The event involves a customer allegation against a device that alarms n56 (replace battery).Testing confirmed that a replace battery alarm (n56) occurred.The history showed the error occurred three times due to the battery not being charged.The battery was charged and reset showing sufficient vdc.The probable cause 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 NEW
• Common Device Name: PUMP INFUSION
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; 9615050; zona franca global,; la aurora heredia ; CS
• MDR Report Key: 7486298
• Report Number: 9615050-2018-00038
• Device Sequence Number: 10803002
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: +M3353001004051$$+70021767699/16D20160604
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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 Catalogue Number: 30010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/04/2018
• 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