MAUDE Adverse Event Report: ST PAUL LEVEL 1 HIGH FLOW FLUID WARMER IV ADMIN SETS; DEVICE, WARMING, BLOOD AND PLASMA

Model Number	DI-300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the assembly of the set, leaks were noticed.No injury or patient involvement.
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
Additional 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 the device history record review.Two pictures were attached and reviewed.Picture, one shows fluid leakage at the joint of the inlet to the heat exchange.Picture two shows a close-up of the y-connection, no leak or defects are visible.The complaint was confirmed.No root cause was determined due to no product being returned for analysis; however, if the product is returned, will reopen this complaint for further investigation.

• Brand Name: LEVEL 1 HIGH FLOW FLUID WARMER IV ADMIN SETS
• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14697574
• Report Number: 3012307300-2022-11958
• Device Sequence Number: 6778085
• Product Code: KZL
• UDI-Device Identifier: 20695085430015
• UDI-Public: 20695085430015
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 05/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2025
• Device Model Number: DI-300
• Device Catalogue Number: DI-300
• Device Lot Number: 4136455
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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