MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION, BLOOD

Lot Number #2602458 & #2607387

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

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

Event Date 02/03/2014

Event Type  malfunction  

Event Description

The smiths medical hotline disposable has been leaking at the junction of the regular iv tubing with the heating core where there is a needle piercing access point.The product is hotline fluid warming set by smiths medical.This has occurred at least 4 times at our facility.The used disposables are sequestered from the following lot numbers: lot # 2602458; exp - 2017-11 lot #2602458; exp - 2017-11 lot #2602458; exp - 2017-11 lot #2607387; exp - 2017-11 on two of these occasions blood was infusing, which both delayed a patient who needed blood in receiving it and wasted part of a unit of blood.

• Brand Name: LEVEL 1 HOTLINE
• Type of Device: WARMER, THERMAL, INFUSION, BLOOD
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd.; arden hills MN 55112
• MDR Report Key: 3732911
• MDR Text Key: 16914048
• Report Number: 3732911
• Device Sequence Number: 1
• Product Code: LGZ
• 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: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: #2602458 & #2607387
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2014
• Patient Sequence Number: 1