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

Model Number	DI-300
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device arrived damaged.Discovered upon opening.No injury.
Additional Manufacturer Narrative
Other text: h6: event problem and evaluation codes: updated.H10: 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 the broken tube can observe in the sample returned.Functional testing with samples of good part taken from the manufacturing process line was compared vs the sample returned by the customer, no difference was identified between those, and they were not easily detached or broken.Issue cannot be confirmed since was could not replicated.Based on the sample returned by the customer and comparison that was made vs a good part taken from the process, it was no possible to replicate the issue, based in the dhr and in process inspection controls parts were tested with no issues reported, the probably root cause can be related transportations issues.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 (b)(4).

• Brand Name: LEVEL 1 FLUID WARMER
• 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: 16704188
• Report Number: 3012307300-2023-03769
• Device Sequence Number: 3676867
• 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: Non-Healthcare Professional
• 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 Expiration Date: 06/10/2025
• Device Model Number: DI-300
• Device Catalogue Number: DI-300
• Device Lot Number: 4136456
• 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
• Date Device Manufactured: 06/28/2021
• 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