MAUDE Adverse Event Report: ST PAUL LEVEL 1 FAST FLOW FLUID WARMER DISPOSABLE; DEVICE, WARMING, BLOOD AND PLASMA

Model Number	DI-300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported of a device malfunction (water leak).Discovered upon opening.No injury.
Additional Manufacturer Narrative
Device manufacturing date: device expiration date could not be determined.Device serial number/lot number is unknown.Event problem and evaluation codes: updated.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found no damages nor other workmanship defects were detected.Functional testing found a leak is observed at the drip chamber.The root cause of the reported issue was found to be a lack of a robust and repeatable adhesive dispensing method, since currently the adhesive application relies on the operators ability to achieve the desired (b)(6) dipping depth.An updated process to add an automated solvent dispenser instead of the current manual process to improve consistency for meeting the process requirements.Closed (b)(6) 2019.Awareness notification to the personal was performed to explain the importance to follow the process for bonding application.Completed (b)(6) 2022.This issue is being monitored via an internal cat.If the occurrence of this issue increases significantly, additional corrective actions will be taken.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# (b)(4).

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER DISPOSABLE
• 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: 16704311
• Report Number: 3012307300-2023-03777
• Device Sequence Number: 14870330
• Product Code: KZL
• UDI-Device Identifier: 20695085430015
• UDI-Public: 20695085430015
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

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 Model Number: DI-300
• Device Catalogue Number: DI-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown