MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-29 for INJECTOR, OPTIVANTAGE DH W/RFID 844003 manufactured by Liebel-flarsheim.
[71478165]
Changing flow rate: the customer is also indicating that it was reported that the flow rate was changed on the control before or during the injection for 1. 5 ml/sec to 4 ml/sec. I instructed the customer to further verify this report. The customer indicated this is what was perceived by the operator of the device that the input flow rate somehow changed during the injection. The customer indicated there is an internal investigation at the hospital to determine what occurred. "patient's iv was flushed with 10 cc of saline manually to test iv. The iv was working sufficiently. Contrast then inject through ct contrast injector, injector was set at 1. 8 cc/sec but equipment malfunctioned and changed to 4 cc/sec. Approx. 50 cc contrast infiltrated. Both the er nurse (xxx) and radiologist (dr. Yyyyy) were notified. The iv was removed and an ice pack was applied. The extremity was elevated per department protocol. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2017-00010 |
| MDR Report Key | 6442228 |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-29 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-03-06 |
| Device Manufacturer Date | 2010-09-30 |
| Date Added to Maude | 2017-03-29 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E. GALBRAITH RD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INJECTOR, OPTIVANTAGE DH W/RFID |
| Generic Name | INJECTOR, OPTIVANTAGE DH W/RFID |
| Product Code | IZQ |
| Date Received | 2017-03-29 |
| Model Number | 844003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E. GALBRAITH RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-29 |