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 Output Problem (3005)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; no information has been provided to date.Device evaluation: one device was received.Per visual inspection, reservoir gasket is worn out, quick connect is corroded, faded line cord, printed circuit board (pcb) pot was damaged, and cracked water tank cover on the bottom right corner.Per functional testing, the potentiometer on the pcb was loose.The complaint was confirmed.The root cause was the pcb was damaged.It was unknown what caused it to become damaged.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.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.

Event Description

It was reported that the device was unable to adjust "r40".The product fault occurred during preventative maintenance.There was no patient involvement and no patient harm/adverse event reported.

• 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 ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18974729
• MDR Text Key: 338558748
• Report Number: 3012307300-2024-01664
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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