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

Catalog Number HL-90

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event, d4: serial number, udi number, expiration date, d5: operator of device, and h4: manufacture date are unknown; no information has been provided to date.H3 - other: device has not been returned to date.Device evaluation: customer's complaint of high frequency of overtemperature when using the hotline for burn surgery could not be confirmed; the device was not returned for evaluation and no evidence was provided for problem confirmation.Based on the reported problem, the most probable cause would be a thermistor malfunction.No serial number has been provided, therefore no device history report (dhr) review could be performed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that there was a high frequency of overtemperature when using the hotline for burn surgery.The room temperature in the operating room was 35 or 36.It could be used without any problems at normal room temperature.The temperature of the instrument itself was quite high to the touch.User attempted to lower the temperature by adding cold circulating water, but it didn't work.The sample was not available for return.There was 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: 18778580
• MDR Text Key: 336668982
• Report Number: 3012307300-2024-00996
• Device Sequence Number: 1
• Product Code: LGZ
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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