MAUDE Adverse Event Report: HOSPIRA, INC. CLAVE LIFESHIELD TWIN SITE EXTENSION SET; IV TUBING (32 INCHE) WITH 2 PORTS

Model Number 12678-28

Device Problems Air Leak (1008); Failure to Infuse (2340); Device Issue (2379)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Respiratory Acidosis (2482)

Event Date 06/30/2014

Event Type  Death  

Event Description

The pt was undergoing an open heart surgery involving a mitral and aortic valve replacement.The patient's surgery was completed and the staff were in the process of moving the patient from the operating table to a hospital bed when she experienced low blood pressure.The pt had a right internal jugular iv access with a swan-ganz catheter.A twin-site extension set (32 inch) with 2 clave ports and option-lok was connected to the ij access with iv fluids connected running to gravity.The physician attempted to administer medications using this iv line when air was noted in approximately 6-8 inches in the iv tubing.In addition, the distal clave port's inner valve was noted to be protruding from the port which left the port i the open position and could not be used.The physician disconnected the twin site extension set from the swan-ganz and aspirated air directly from the swan-ganz.The patient decompensated, cpr was in progress and she was kept on the operating table and required re-exploration.It is unclear as to how the inner valve of the port became protruded, the air was in the line and the role this played in the pt's decompensation.

• Brand Name: CLAVE LIFESHIELD TWIN SITE EXTENSION SET
• Type of Device: IV TUBING (32 INCHE) WITH 2 PORTS
• Manufacturer (Section D): HOSPIRA, INC.; lake forest IL
• MDR Report Key: 4050937
• MDR Text Key: 4860480
• Report Number: 4050937
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12678-28
• Device Lot Number: 32 236 4W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Other
• Patient Age: 62 YR