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

Model Number L-70

Device Problem Defective Device (2588)

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

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed the female luer was damaged customer's reported issue was not duplicated.A leak testing was performed, and no discrepancies were detected during the testing.A final audit on the visual inspection process was made, no discrepancies were observed.The training records of the operators were reviewed, and no discrepancies were found.The root cause of the reported issue was determined.The female lure became damaged after the product left the facilities.Actions taken to mitigate the reported issue: as a preventive action, a notification of this complaint to the production personnel was conducted by the quality engineer.

Event Description

It was reported that immediately after starting to use the product, the customer found a crack in the part where the blood transfusion bag and the hot line warming tube, eventually, blood leaked from the cracked part.After they replaced the tube with another new one, the product was able to be used without problem.No patient injury reported.

• Brand Name: HOTLINE WARMING SET
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15656598
• MDR Text Key: 306609358
• Report Number: 3012307300-2022-25995
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: 30695085407007
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• 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
• Report Date: 10/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: L-70
• Device Catalogue Number: L-70
• Device Lot Number: 3658757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1