MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC., LEVEL 1 HOTLINE® FLUID WARMING SET; WARMER, THERMAL, INFUSION FLUID

Catalog Number L-70NI

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

User facility reported that the disposable warming fluid infusion line was found leaking during setup.The disposable's inner lumen and outer lumen were reportedly breached which allowed the recirculating solution to mix with the infusate.No patient injury as the reported product issue was discovered upon setup and priming.

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

Manufacturer Narrative

One sample was returned for evaluation.Visual inspection confirmed the returned connector to not be properly inserted into the 3 lumen tube.Functional testing was performed by connecting the returned sample to the hl-90 hotline fluid warmer unit.A breach was found in the bonding between the return connector and 3 lumen tube; the fluids were mixed.Manufacturing process review was performed and all procedures were found to be carried out appropriately.A review of the leak testing was conducted with no discrepancies detected during 32 units tested.A sample of 32 units was taken in order to verify that the 3 lumen tube was properly inserted to the return connector; no discrepancies were found.Leak testers are verified by quality on a daily basis to ensure they are capable of detecting leaks.The leak tester is capable of detecting leaks in the inner tube of the triple lumen tube and the external tube.The most probably causes of the reported issue is that the 3 lumen tube was not properly inserted due to a collapsed end of the 3 lumen tube or the segregation of rejected product after performing the leak test was not properly conducted.Corrective action was taken by adding a picture of a 3 lumen tube with a collapsed end as a non-acceptable condition.A picture of a 3 lumen tube not properly inserted to the return connector was also added.All assemblies that do not pass either or both, water or fluid path pressure tests, prior to removing the assembly from the fixture of the tester, will have a red tape strip placed around the 3 lumen tube.Once the red tape strip has been placed, the assembly will be placed in a locked container for non-conforming material.The locked container will be emptied every 3 hours, or whenever full, by quality assurance or a person assigned by supervisor only.Retraining of the production personnel was conducted in order to reinforce the correct segregation of the products rejected after the leak test operation.

• Brand Name: LEVEL 1 HOTLINE® FLUID WARMING SET
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.,; 160 weymouth st.; rockland MA 02370
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.,; 160 weymouth st.; rockland MA 02370
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4949514
• MDR Text Key: 20724362
• Report Number: 2183502-2015-00550
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: L-70NI
• Device Lot Number: 2927412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1