MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for OPTIVANTAGE DH 844001 manufactured by Liebel-flarsheim.
[126089586]
Overall investigation summary is as follows: incident: extravasation event. Inspection of equipment requested. Regional service completed general inspection of injector, conducted performance tests according to protocol and verified flow rate & pressure limits were within permitted range. Service stated "the reported problem (was) attributable to bad connection to patient. No pressure problems found. Equipment is operational. " the injector does not have the capability to prevent or detect an extravasation (infiltration). However, precautions to minimize an extravasation are provided in the operator's manual. Additionally, described in the manual are i. V. Site patency check techniques, including a manual method and another using a patency key in the setup screen. Cts history search shows no other similar issues with this unit. Root/probable cause code is as follows: personnel - performance - failed to follow procedure - service stated "the reported problem (was) attributable to bad connection to patient. No pressure problems found. Equipment is operational. " no further investigation needed at this time. Qa will continue to monitor and trend for similar issues. No capa at this time, these trends and issues are reported on during quality metrics reviews and during the management review meetings to consider input for corrective action. Disposition summary is as follows: service conducted performance and verified flow rate & pressure limits were within permitted range. Service stated "the reported problem (was) attributable to bad connection to patient. No pressure problems found. Equipment is operational. "
Patient Sequence No: 1, Text Type: N, H10
[126089587]
This incident took place on (b)(6) 2018 as an extravasation event. The reporter of the event stated that the event occured during a procedure and that the procedure was not completed. She stated that there was an injury to the patient in the form of an extravasation. She also stated that there were no error codes that presented during this case. The reporter requested that the equipment be inspected. On 12 september 2018, a general inspection was completed on the injector, including completion of performance tests according to protocol, verified flow rate and pressure limits were within permitted range. Reported problem attributable to bad connection to patient. No pressure problems were found and the equipment is operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00038 |
| MDR Report Key | 7962991 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-09-11 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2018-10-12 |
| 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 | FRED RECKELHOFF |
| Manufacturer Street | 2111 E GALBRAITH ROAD |
| 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 | OPTIVANTAGE DH |
| Generic Name | OPTIVANTAGE DH |
| Product Code | IZQ |
| Date Received | 2018-10-12 |
| Model Number | 844001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |