MAUDE Adverse Event Report: ICU MEDICAL, INC. PRIMARY PLUM SET; IV TUBING

Model Number 14687-28

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 11/15/2018

Event Type  Death  

Event Description

Iv tubing primary plum set clave port, clave y-site, secure lock, 103 inch tubing, item #14687-28 was being utilized to infuse normal saline through the sheath of the pt's central line.The central line was in the pt's right internal jugular vein.The iv line disconnected from the secure lock and the pt hemorrhaged from the central venous catheter.

• Brand Name: PRIMARY PLUM SET
• Type of Device: IV TUBING
• Manufacturer (Section D): ICU MEDICAL, INC. ; 600 north field dr bldg h2-1e; lake forest IL 60045
• MDR Report Key: 8126008
• MDR Text Key: 129170441
• Report Number: 8126008
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14687-28
• Device Catalogue Number: 1468728
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2018
• Distributor Facility Aware Date: 11/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 81