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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT HYPERTHERMIA PUMP; THERMAL INFUSION FLUID WARMER
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BELMONT MEDICAL TECHNOLOGIES THE BELMONT HYPERTHERMIA PUMP; THERMAL INFUSION FLUID WARMER Back to Search Results
Model Number HYPERTHERMIA PUMP
Medical Device Problem Code Intermittent Loss of Power (4016)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/27/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The hardware device was received by belmont for evaluation on april 26, 2019.The investigation is not yet complete.A follow-up report with all additional relevant information will be submitted upon completion of the investigation.
 
Event or Problem Description
Our distributor received a complaint from the user facility and reported that during a case, the unit turned off by itself during the priming process.The staff was unable to power it back on.Another unit was brought in to finish the case and the patient was not harmed.
 
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Brand Name
THE BELMONT HYPERTHERMIA PUMP
Common Device Name
THERMAL INFUSION FLUID WARMER
Manufacturer (Section D)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica MA 01821
MDR Report Key8559629
Report Number1219702-2019-00026
Device Sequence Number2092083
Product Code LGZ
UDI-Device Identifier10896128002456
UDI-Public(01)10896128002456
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K152208
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/28/2019
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
Operator of Device Health Professional
Device Model NumberHYPERTHERMIA PUMP
Device Catalogue Number902-00001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/29/2019
Initial Report FDA Received Date04/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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