MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES BELMONT HYPERTHERMIC PUMP; WARMER, THERMAL, INFUSION FLUID

Device Problems Overheating of Device (1437); Unable to Obtain Readings (1516)

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

Event Date 10/17/2022

Event Type  malfunction  

Event Description

Belmont hyperthermic pump s/n (b)(4) gave a overheat alarm when beginning to fill the patient.Turned off machine and restarted machine and received same error.Obtained second machine s/n (b)(4) and changed disposables to second machine, added a forth temp probe which also did not read any temp.Fda safety report id #(b)(4).

• Brand Name: BELMONT HYPERTHERMIC PUMP
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES
• MDR Report Key: 15715613
• MDR Text Key: 303152778
• Report Number: MW5113024
• Device Sequence Number: 2
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/31/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female