MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: 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 Description

It was reported that the power turned on and off, and the behavior was inconsistent.Also, the coating near the outlet was peeling off.There was unknown patient involvement and unknown patient harm/adverse event reported.

Manufacturer Narrative

Evaluation codes: updated.Device evaluation: one device was received.Per visual inspection, the rubber feet on the bottom of the unit had melted and ¿disappeared¿.It was also noted that there were cracks in the main cabinet.The complaint was confirmed through functional testing as the power does not turn on and off.The root cause was the ac power cord was broken due to mechanical shock such as a drop.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.At the customer's request, the product was returned without repair.D3 - address.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18861285
• MDR Text Key: 337558035
• Report Number: 2183161-2024-00184
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)081009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: HL-90JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1