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

Catalog Number	DI-100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: b3: date of event is unknown, no information has been provided to date.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 the customer was completing a test run.The 500cc "dad" bag was connected to purge; solution leak was found in the "y" that was divided for each infusion chamber or connection to each fluid.There was no patient involvement, no injury or harm.It was reported there were four (4) items involved.
Additional Manufacturer Narrative
One (1) video and one (1) photo were provided by the customer which were used to conduct the device analysis since the physical device was not returned.The video shows a normothermic iv administration set connected to a fast flow fluid warmer; one of the spikes is connected to an iv bag filled with a clear liquid, as the video continues it focused on the 3-y connector where liquid is observed to be dripping from the joint between the drip chamber tail and 3-y connector.The photo shows a close-up of the 3-y connector and drip chamber; the leak was not visible in the photo.The video confirmed the complaint as leaking was observed.Because the physical device was not returned the root cause could not be determined.A device history record (dhr) review showed no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will be monitored, and further actions taken accordingly.

• 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: 17450696
• Report Number: 3012307300-2023-07763
• Device Sequence Number: 20678364
• Product Code: KZL
• UDI-Device Identifier: 20695085410017
• UDI-Public: 20695085410017
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 08/02/2025
• Device Catalogue Number: DI-100
• Device Lot Number: 4170271
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/20/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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