MAUDE Adverse Event Report: ST PAUL LEVEL 1 TRAUMA FAST FLOW DISPOSABLES; DEVICE, WARMING. BLOOD AND PLASMA

Model Number	DI-100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: 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.One unit was returned for evaluation; the returned unit was received in decontaminated condition inside a plastic bag without its original packaging.The complainant returned unit was visually inspected at 12in to 16in under normal conditions of illumination.No damages nor other workmanship defects were detected.The unit was tested for leak by introducing colored water in the product.It was found leak from the drip chamber.The root cause of the reported issue was found to be the most probable root cause is that during the drip chamber assembly the solvent is not applied in the desired 1/8in dipping depth.Actions were taken to mitigate the reported issue: update the manufacturing process due the implementation of the new medical solvent dispenser, the operations of the drip chamber assembly were updated for refer the new dispenser.
Event or Problem Description
It was reported that the device was leaking when device was pressurized prior to use.No patient injury was reported.

• Brand Name: LEVEL 1 TRAUMA FAST FLOW DISPOSABLES
• 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: 16859750
• Report Number: 3012307300-2023-04951
• Device Sequence Number: 5730427
• Product Code: KZL
• UDI-Device Identifier: 20695085410017
• UDI-Public: 20695085410017
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 05/23/2023
• Device Model Number: DI-100
• Device Catalogue Number: DI-100
• Device Lot Number: 3805520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• 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: 04/21/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2019
• 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