MAUDE Adverse Event Report: LEVEL 1; WARMER, THERMAL, INFUSION FLUID

Model Number L-70

Device Problem Defective Component (2292)

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

Event Date 03/01/2021

Event Type  malfunction  

Event Description

Information was received indicating that during pre-use check, the customer noticed that a smiths medical level 1 hotline connector did not turn.There was no patient injury.

Event Description

Investigation completed and summary in h 10.

Manufacturer Narrative

Other, other text: investigation completed on a smiths medical fluid warming|level 1 hotline disposables the complaint of connector did not turn was confirmed.Two images received but complaint was unable to be verified in the pictures.Samples mtij p/n l-70 with lot number 4034461 reported in complaint.Reflux connector the connector didn?t turn, therefore failure mode reported can be confirmed.Based on the sample provided, analysis conducted on physically evaluation, and rmp 1034 rev.100 root cause can be determined as solvent excess applied to connector.Manufacturing reviewed and device passed 100 percent leak testing prior to release.Action was taken to notify quality engineer on the reported complaint and finding.

• Brand Name: LEVEL 1
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• MDR Report Key: 11636530
• MDR Text Key: 244603559
• Report Number: 3012307300-2021-02954
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: 30695085407007
• Combination Product (y/n): N
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: L-70
• Device Catalogue Number: L-70
• Device Lot Number: 4034461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• 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