MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-22 for THE BELMONT RAPID INFUSER RI-2 903-00039 manufactured by Belmont Medical Technologies.
[139579712]
The device was returned for investigation and was tested using our standard operating procedures. We were unable to confirm the customer complaint; the unit performed according to our specifications. The manufacturing records for this serial number were reviewed and nothing notable was observed. The user facility has not returned the disposable set for investigation, nor has a lot number been provided. A chart is provided on page 10 of the operator's manual to help the user choose an appropriate cannula size for the desired flow rate and infusate. The cannula size used in this case was not reported. We will continue to reach out to the user facility to obtain more details about the case and the disposable set. Without additional information, it is difficult to determine what occurred in this case. Should additional information become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[139579713]
Belmont's sales representative received a complaint from the user facility and relayed the following report: "customer called about an event 2 weeks ago in the sicu. She was unsure what error message was on the screen during a mass transfusion. She said she thought it kept saying temperature too low, but she was not sure. She also could not get the flow rate over 20ml/min. She was using a large quinton catheter. It did start off well and then they started getting alarms 5 minutes into transfusion. " the biomed was unable to duplicate the issue but requested to send the unit back for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219702-2019-00015 |
| MDR Report Key | 8444413 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-20 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SABRINA BELLADUE |
| Manufacturer Street | 780 BOSTON ROAD |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 9783307637 |
| Manufacturer G1 | BELMONT MEDICAL TECHNOLOGIES |
| Manufacturer Street | 780 BOSTON ROAD |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE BELMONT RAPID INFUSER |
| Generic Name | THERMAL INFUSION FLUID WARMER |
| Product Code | LGZ |
| Date Received | 2019-03-22 |
| Returned To Mfg | 2019-03-11 |
| Model Number | RI-2 |
| Catalog Number | 903-00039 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BELMONT MEDICAL TECHNOLOGIES |
| Manufacturer Address | 780 BOSTON ROAD BILLERICA MA 01821 US 01821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |