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	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturing date and device expiration date could not be determined.Device serial number/lot number is unknown.Event problem and evaluation codes: updated.No lot number was provided; therefore, device history record review could not be performed.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 the leak is not observed in the unit.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported of a device malfunction (water leak).Lot unknown.Discovered upon opening.No injury.

• 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: 16725477
• Report Number: 3012307300-2023-04021
• Device Sequence Number: 20862132
• Product Code: KZL
• UDI-Device Identifier: 20695085410017
• UDI-Public: 20695085410017
• 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): 04/12/2023

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-100
• Device Catalogue Number: DI-100
• 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: 04/15/2022
• Initial Report FDA Received Date: 04/12/2023
• 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