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

Model Number 2066828

Device Problems Leak/Splash (1354); Occlusion Within Device (1423); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2017

Event Type  malfunction  

Event Description

The oncoming nurse continued to smell tpn when walking up to the patient's bedside.Nurse started investigating iv tubing for a leak.Bottom of the bed was saturated with tpn and a leak was noted at the filter.Filter was changed.Once the filter was changed, iv pump began to indicate a distal occlusion and the peripheral iv would not flush.A new peripheral iv had to be started, previous site disconnected.

• Brand Name: LIFESHIELD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 6525424
• MDR Text Key: 73805326
• Report Number: 6525424
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2066828
• Device Catalogue Number: 2066828
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.; UNKNOWN,
• Patient Outcome(s): Other