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

Model Number L-70

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Customer facility phone number: (b)(4).

Event Description

Information was received indicating that a smiths medical fluid warmer accessory was found to have damage in the twin-tube connector.There was no patient injury and no reported adverse events.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.A sample was received for evaluation.The sample unit was received with its original packaging open.During visual inspection, the sample was visually inspected under normal lighting.The following components were inspected: tube surface, luer lock adapter, reflux connector w/ ports and the assembly connector swivel return.Visual inspection showed no marks or stains were observed on tube surface, reflux connector or swivel connector.However, there was visible cracking in the luer lock adapter, failure mode reported can be observed.During functional testing, a leakage test was performed to verify if leakage can be caused by cracking on luer connector.The sample did not pass the leakage test.Based on the sample provided, the analysis conducted and the trend analysis for this failure mode in complaints, root cause can be determined as supplier item fault.Based on root cause determined following actions will be taken: a supplier corrective action report was submitted to supplier for the luer connector and a containment awareness notification for this failure mode was reported to production personnel.

• Brand Name: LEVEL 1 FLUID WARMER ACCESSORY
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2jo kudaru, kawaharamachidori,; minneapolis, MN 55442
• MDR Report Key: 12152314
• MDR Text Key: 261049324
• Report Number: 3012307300-2021-07137
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: 30695085407007
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Device Model Number: L-70
• Device Lot Number: 4073188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 09/12/2021
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1