MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-03-01 for OPTIVANTAGE DH 844001 manufactured by Liebel-flarsheim Co..
[586230]
Lf technical support reports via fax that customer states; "protocol was set to deliver 1. 5cc per second. Upon start of injection rate jumped to 7. 5cc per second. 2/2: customer states that nurse set the protocol manually on the console before she went into the ct suite to start the iv. Once iv was started & connected to the injector system, she asked the technologist in the ct control room if she could start the injection. Technologist acknowledged. The nurse started the injection. Nurse immediately realized by the sound that something was wrong and when she looked back at the powerhead, she saw the rate was 7. 5. The system stalled at that time, so the injection was not totally completed. System reset and procedure completed without any further incident. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
[7822192]
The returned injector was evaluated by the product engineering. Findings are as follows: the first thing done was to review the shot history of the injector. Inside the history file, numerous injections with flow rates of 2. 0ml/sec or lower were found. There was one injector that indicated a 7. 5ml/sec flow rate which is believed to be the shot in question on the complaint. The history indicates (on 1/3/07) that the 7. 5ml/sec flow rate was programmed and run for a volume of 16ml. At that time, the injection stopped via operator interaction or injector stalling. The complaint indicates that it stalled and, although it is not known the restriction that they were running through, it would be assumed it did based on the 7. 5ml/sec flow rate. There were 9 various injections (all at or below 2. 0ml/sec) run on this injector on february 2nd and 3rd. These were performed by field service engineer (our field service technician) in an attempt to repeat the failure. Internally here, we checked the results history as well as running 3 more shots at low flow rates and could not duplicate the failure. In conclusion, it seems that the injector ran the programmed shot of 7. 5ml/sec for a length of 16mm upon which the injector stalled based on too high a flow for the restriction used. The history file indicates that this was the programmed flow. There is no evidence of the injector running a different flow rate (7. 5) than customer indicates programming (1. 5).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2007-00005 |
| MDR Report Key | 823237 |
| Report Source | 05,06,07 |
| Date Received | 2007-03-01 |
| Date of Report | 2007-02-02 |
| Date Mfgr Received | 2007-02-02 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2007-03-07 |
| 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 | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIVANTAGE DH |
| Generic Name | CT POWER INJECTOR SYSTEM |
| Product Code | IZO |
| Date Received | 2007-03-01 |
| Model Number | OPTIVANTAGE DH |
| Catalog Number | 844001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 810642 |
| Manufacturer | LIEBEL-FLARSHEIM CO. |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US |
| Baseline Brand Name | OPTIVANTAGE DH |
| Baseline Generic Name | POWER INJECTOR SYSTEM |
| Baseline Model No | OPTIVANTAGE DH |
| Baseline Catalog No | 844001 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-01 |