MAUDE Adverse Event Report: HOSPIRA, INC. LIFESHIELD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2065428
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: rn into to turn patient with another rn.Primary rn checked lines to make sure there was enough slack before turning which there was.When turning the patient, primary rn noticed blood on the bed and found the iv connection tubing to be dislodged from the hub without any tension on the tubing.Epinephrine was running through the tubing at the time, rn quickly switched epinephrine to picc line.Rn noticed pressure drop to 99 systolic for a short period of time then bp returned to previous systolic number of 120-130 within an expected timeframe.

• Brand Name: LIFESHIELD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 10739859
• Report Number: 10739859
• Device Sequence Number: 1191578
• Product Code: FPA
• UDI-Device Identifier: 10887787005858
• UDI-Public: (01)10887787005858
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020
• Report Date (Section F): 10/16/2020

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: No Information
• Device Model Number: 2065428
• Device Catalogue Number: 2065428
• Device Lot Number: 3907078
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 136
• Date Report Sent to FDA: 10/16/2020