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  

Manufacturer Narrative

Other text: 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.

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

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, icu medical will reopen this complaint for further investigation.A device history (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.For all enquiries or follow-up questions related to the record, do not use (b)(4) located in sections g.1., please direct those to the following: (b)(4).

• 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: 17226623
• MDR Text Key: 318209802
• Report Number: 3012307300-2023-06860
• 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