MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-03-04 for OPTIVANTAGE V5 DH PEDESTAL SY V8431 manufactured by Liebel-flarsheim.
[4328527]
Customer reports a left hand extravasation on an oncology patient with thin vein walls. The injection was at 2ml/s for a volume of 90ml. Optiray 350, 125ml prefilled syringe was loaded into the optivantage dh injector system. Staff reports compression treatment was provided, with the infiltrated amount unknown. The patient was not hospitalized due to the procedure. The patient was an inpatient, whose stay was not extended due to the event. The physician does not know the amount of fluid that infiltrated. It is reported the patient recovered.
Patient Sequence No: 1, Text Type: D, B5
[11601061]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2014-00018 |
| MDR Report Key | 3724502 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-02-05 |
| Date of Event | 2014-01-29 |
| Date Mfgr Received | 2014-02-05 |
| Date Added to Maude | 2014-04-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIVANTAGE V5 DH PEDESTAL SY |
| Product Code | IZQ |
| Date Received | 2014-03-04 |
| Model Number | OPTIVANTAGE V5 DH |
| Catalog Number | V8431 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-04 |