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

Model Number D-100

Device Problems Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889); Scratched Material (3020)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

It was reported that upon opening, there were kinks in the line, slice marks in tubing, and leaking at connection points.Two lot numbers, 4344926 and 4273794, were reported.No adverse patient effects or injury were reported by the customer.

Manufacturer Narrative

D4: expiration date and h4: manufacture date are unknown.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.

Manufacturer Narrative

Additional information is provided for h.2 and h.6.No product was returned.If the product is returned this complaint will be reopened for further investigation.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).

• Brand Name: LEVEL 1 FLUID WARMER IV SET
• 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: 17226496
• MDR Text Key: 318113163
• Report Number: 3012307300-2023-06854
• Device Sequence Number: 1
• Product Code: KZL
• UDI-Device Identifier: 40695085410004
• UDI-Public: 40695085410004
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-100
• Device Catalogue Number: D-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1