MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-08 for MEDEX? C-FUSOR? 500ML PRESSURE INFUSOR MX4805 manufactured by Smiths Medical Asd, Inc..
[74704816]
Initial reporter provided a catalog number of mx4805. Company representative provided a catalog number of mx4805 and a lot number of 3084243; however, the lot number 3084243 corresponds with the catalog number a4805. Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[74704817]
It was reported medex? C-fusor? 500ml pressure infusor was deflating while in use. It was noted that the device had been use for "some weeks / months" when the fault occurred. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-01016 |
| MDR Report Key | 6552440 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-08 |
| Date of Report | 2017-05-08 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-04-18 |
| Date Added to Maude | 2017-05-08 |
| 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 | LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL ASD INC. |
| Manufacturer Street | 6250 SHIER RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDEX? C-FUSOR? 500ML PRESSURE INFUSOR |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-05-08 |
| Catalog Number | MX4805 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-08 |