MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER, 230 VOLT GERMAN MODEL; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the water tank was leaking.No additional available information regarding the event.Patient involvement is unknown.

Manufacturer Narrative

B3: date of event and d5: operator of device are unknown; no information has been provided to date.Device analysis: one device was returned for investigation.Visual inspection found the unit looks to be in used conditions.Water tank has cracks in all 4 corners.Functional testing confirmed the complaint; the device was leaking.Root cause was attributed to the broken water tank cover.What caused this condition was not established.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.Tank cover replaced.Device passed functional, electrical, and safety tests after the tank was replaced.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER, 230 VOLT GERMAN MODEL
• 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: 18642040
• MDR Text Key: 334743593
• Report Number: 3012307300-2024-00545
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2024

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-DE-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• 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