MAUDE Adverse Event Report: ST PAUL LEVEL 1 HIGH FLOW FLUID WARMER IV ADMIN SETS; DEVICE, WARMING, BLOOD AND PLASMA

Model Number DI-60HL

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that the device was received kinked out of package.No adverse affects or patient harm have been reported.

Manufacturer Narrative

No product was returned.We are unable to confirm the reported complaint.If the product is returned, icu medical will reopen this complaint for further investigation.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this products.

• Brand Name: LEVEL 1 HIGH FLOW FLUID WARMER IV ADMIN SETS
• Type of Device: 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: 17162388
• MDR Text Key: 317469189
• Report Number: 3012307300-2023-06318
• Device Sequence Number: 1
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: 20695085406010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK860023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DI-60HL
• Device Catalogue Number: DI-60HL
• Device Lot Number: 4114262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1