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

Model Number HL-90

Device Problems Device Alarm System (1012); Fracture (1260); Insufficient Heating (1287)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d5.Operator of device is 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 device has a crack in the main body.Error alarm sound doesn't stop.Water doesn't warm.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

One warmer device was received for investigation.During visual inspection, cracks were observed on the cover of the circulating water tank.The reported issue was confirmed during functional testing when the device temperature display was inaccurate and then overt temperature alarm was activated.The investigation traced the issue to the device circuit board, which was determined to be damaged.The investigation attributed the root cause of this condition to a physical impact.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.Per the customer's request, no repairs were performed on the device, and it was returned to the customer.

• 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: 18658369
• MDR Text Key: 334799241
• Report Number: 3012307300-2024-00603
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-90JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2012
• 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