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

Catalog Number	30010
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.
Event or Problem Description
The event involved a customer allegation that the device alarmed for n56 (replace battery).This plum 360 device has software version 15.02.00.008.The plum 360 software triggers a ¿replace battery¿ alarm after three bad battery counts.Due to a defect in software version 15.02.00.008, the alarm is generated as ¿depleted battery¿ instead of ¿replace battery,¿ which causes the device to enter a shutdown sequence once ac is unplugged.
Additional Manufacturer Narrative
Testing and investigation confirmed the complaint of n56 (replace battery) in the history log.The pump passed pvt tests, but failed the run-in protocol of 25ml/hr and 7 hours for battery life test.After the battery was replaced, the pump passed the run-in protocol for battery life test.The probable cause is a defective battery.This reported complaint was determined to be associated with a known s/w defect which 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.
Event or Problem Description
The event involved a customer allegation that the device alarmed for n56 (replace battery).This plum 360 device has software version 15.02.00.008.The plum 360 software triggers a ¿replace battery¿ alarm after three bad battery counts.Due to a defect in software version 15.02.00.008, the alarm is generated as ¿depleted battery¿ instead of ¿replace battery,¿ which causes the device to enter a shutdown sequence once ac is unplugged.

• 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: 7504042
• Report Number: 9615050-2018-00039
• Device Sequence Number: 11187077
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: +M3353001004051$$+70020004921/16D20160227
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: 05/10/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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