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

Model Number	L-370
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a smiths medical hotline tubing observed with kinks.It was noted these are kinked within the packaging.At least one instance was while in use with a patient.The fluid would not run because of it.
Additional Manufacturer Narrative
Additional information: the reporter provided device photographs for evaluation.The device photographs were examined by investigators and the photographs were too unclear to allow for cause to be identified.The reported issue could not be confirmed via the photographs provided.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.This device type is 100% functionally tested to identify leaks or occlusions.
Event or Problem Description
Additional event information: reporter stated the tubing was blocked and fluid would not run.Device was not used with patient.

• Brand Name: LEVEL 1
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10912735
• Report Number: 3012307300-2020-11850
• Device Sequence Number: 3006930
• Product Code: LGZ
• UDI-Device Identifier: 10695085002819
• UDI-Public: 10695085002819
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: L-370
• Device Catalogue Number: L-370
• Device Lot Number: 4034402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/12/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1