MAUDE Adverse Event Report: ST PAUL LEVEL 1 FLUID WARMER IV SET; DEVICE, WARMING, BLOOD AND PLASMA

Model Number	D-100
Medical Device Problem Codes	Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: expiration date and h4: manufacture date are unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that upon opening, there were kinks in the line, slice marks in tubing, and leaking at connection points.Two lot numbers, 4344926 and 4273794, were reported.No adverse patient effects or injury were reported by the customer.
Additional Manufacturer Narrative
Email is: (b)(6).No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: LEVEL 1 FLUID WARMER IV SET
• Common Device Name: DEVICE, WARMING, BLOOD AND PLASMA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17226573
• Report Number: 3012307300-2023-06856
• Device Sequence Number: 15224517
• Product Code: KZL
• UDI-Device Identifier: 40695085410004
• UDI-Public: 40695085410004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: Health Professional
• Device Model Number: D-100
• Device Catalogue Number: D-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown