MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for INJECTOR, OPTIVANTAGE DH W/RFID 844003 manufactured by Liebel Flarsheim.
[28376310]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[28376311]
Customer reports during a cta chest on a female patient of unknown age, the injector was set for 3ml/sec flow rate, but delivered 9ml/sec flow rate. They stated that half way through the injection it started beeping and they were watching the console screen when it changed. There was no reported injury to the patient and the procedure was completed without incident. No other factors changed other than the flow rate.
Patient Sequence No: 1, Text Type: D, B5
[33959343]
Customer reports during a computed tomography angiogram (cta) chest on a female patient of unknown age, the injector was set for 3ml/sec flow rate, but delivered 9ml/sec flow rate. They stated that half way through the injection it started beeping and they were watching the console screen when it changed. There was no reported injury to the patient and the procedure was completed without incident. No other factors changed other than the flow rate. According to the contact, aggie, who was not the tech who did the injection, she only knows that at the end of the injection, the flow rate showed 9ml/s. She thinks the tech in question inadvertently changed the rate before injecting by bumping the screen. The results history was no longer available when the field service engineer (fse) was there. Review of alarm history showed no alarm codes around the sept 17 timeframe when the incident occurred. The fse found no problems with injector and verified proper operation according to the service checklist (p/n 844864). The injector prevents the programmed flowrate from being changed after the injection is enabled. The injector monitors flow rate and if it exceeds the programmed value, an alarm would have resulted, alerting the user of the injector problem. The injector mitigates inadvertent flowrate entry by requiring user to press touchscreen twice to enter flowrate- one press to display slide bar, second press to set programmed value on slide bar. Based on the available evidence, no injector malfunction occurred and the root cause is user error. No further investigation needed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2015-00098 |
| MDR Report Key | 5141729 |
| Date Received | 2015-10-09 |
| Date of Report | 2015-10-21 |
| Date of Event | 2015-09-17 |
| Date Mfgr Received | 2015-09-17 |
| Device Manufacturer Date | 2012-09-30 |
| Date Added to Maude | 2015-10-09 |
| 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 | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| 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 | INJECTOR, OPTIVANTAGE DH W/RFID |
| Generic Name | INJECTOR, OPTIVANTAGE DH W/RFID |
| Product Code | IZQ |
| Date Received | 2015-10-09 |
| Model Number | INJECTOR, OPTIVANTAGE DH W/RFID |
| Catalog Number | 844003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-09 |