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

Model Number HL-90

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided to date.D5.Other operator of device: operator of device is unknown.(b)(6).Investigation summary: one low flow fluid warmer was received for evaluation.Visual inspection found that the on/off switch was faulty and identified as the root cause, confirming the customers complaint.Additionally, the pwa led was found damaged, the pole clamp was broken, the pump was found to be rusty, and the water tank enclosure was moldy.Based on the damaged parts and mold, it was decided that the device would be scrapped.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

Event Description

It was reported that the device on/off switch was faulty.There was unknown patient involvement and unknown patient harm/adverse event reported.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE FLUID AND BLOOD WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18642008
• MDR Text Key: 334566033
• Report Number: 2183161-2024-00123
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: HL-90-UK-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2002
• 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