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U.S. Department of Health and Human Services

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

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HOSPIRA, INC. LIFESHIELD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameLIFESHIELD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
HOSPIRA, INC.
highway 301 north
rocky mount NC 27801
MDR Report Key6525424
MDR Text Key73805326
Report Number6525424
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received04/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2066828
Device Catalogue Number2066828
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2017
Event Location Hospital
Date Report to Manufacturer04/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/27/2017 Patient Sequence Number: 1
Treatment
NOT APPLICABLE.; UNKNOWN,
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