MAUDE Adverse Event Report: HOSPIRA, INC. LIFECARE PCA; PUMP, INFUSION, PCA

Model Number	0483148
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Unit failed during patient use.Pump stopped infusing and displayed "malfunction" message and sounded alarm.Nurse had to turn off device in order to silence unit.Unit was brought to clinical engineering for inspection.Pump turned on and passed self-test without any problems, connected unit to (b)(4) software to review logs but all data was lost, log repository was empty.

• Brand Name: LIFECARE PCA
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 7482851
• Report Number: 7482851
• Device Sequence Number: 18868221
• Product Code: MEA
• UDI-Device Identifier: 10887787005032
• UDI-Public: (01)10887787005032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2018
• Report Date (Section F): 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: Lay User/Patient
• Device Model Number: 0483148
• Device Catalogue Number: 0483148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.
• Date Report Sent to FDA: 04/25/2018