MAUDE Adverse Event Report: ST PAUL LEVEL 1; WARMING

Model Number DI-50

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 07/31/2021

Event Type  malfunction  

Event Description

Information received a smiths medical fluid warming|level 1 trauma fast flow disposables was removed from packaging and found a defective filling chamber, which was not revealed in the plastic.No patient involvement.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the joint between the 3-way connector and the single port cap is broken.Functional testing found based on the test performed, it is concluded that the failure reported could be reproduced by bending the assembly with force.And it can be observed that the cuts in the tested unit are like the cuts in the complainant units.The root cause of the issue could not be determined; the most probable is that the product become damaged after it left manufacturing site.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.

• Brand Name: LEVEL 1
• Type of Device: WARMING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12392178
• MDR Text Key: 268939055
• Report Number: 3012307300-2021-09009
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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 Expiration Date: 08/18/2023
• Device Model Number: DI-50
• Device Catalogue Number: DI-50
• Device Lot Number: 4033686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/05/2021
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• 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