FDA Adverse Event
Injury
Summary report: N
THE BELMONT 3 SPIKE DISPOSABLE SET
MDR report key: 8420644
·
Received March 13, 2019
Report
- Report Number
- MW5084891
- Event Type
- Injury
- Date Received
- March 13, 2019
- Date of Event
- January 17, 2019
- Report Date
- March 8, 2019
- Manufacturer
- BELMONT INSTRUMENT LLC/ BELMONT MEDICAL TECHNOLOGIES
- Product Code
- FRN
- UDI-DI
- 00896128002022
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE BELMONT RAPID INFUSER# (B)(4) WAS BEING USED FOR A SURGICAL CASE DUE TO NEED TO GIVE A HIGH VOLUME OF BLOOD PRODUCTS. THE MACHINE WAS BEING USED CORRECTLY WHEN AN ERROR CODE FOR A "HIGH TEMPERATURE" WAS NOTED. THE RAPID INFUSER WAS TURNED OFF AND RESTARTED WITH NO FURTHER ERROR CODES. AFTER APPROXIMATELY TEN MINUTES OF USE, THE MACHINE STARTED TO SMOKE. THE MACHINE WAS PROMPTLY TAKEN OUT OF SERVICE. UPON LATER REVIEW, IT WAS NOTED THAT THE INTERNAL TUBING (THE BELMONT 3 SPIKE DISPOSABLE SET) WAS CLOTTED, CHARRED AND SLIGHTLY MELTED. A SMALL PORTION OF THE HEAT EXCHANGER WAS NOTED TO BE BLACKENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209014 | THE BELMONT 3 SPIKE DISPOSABLE SET | PUMP INFUSION | FRN | BELMONT INSTRUMENT LLC/ BELMONT MEDICAL TECHNOLOGIES | 903-00006P | 00896128002022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |