MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-03-15 for INJ. OPTIV DH,SI W/OEM 844005 manufactured by Liebel Flarsheim.
[40342001]
The customer reported an air injection occurred during a procedure. A regional service engineer removed the injector from the customer site and took it their service center and found the injector to be within manufacturers specifications. There were no problems or malfunctions detected that would cause a problem with this injector. Air injections are typically not caused by an injector malfunction. The injector was cycled many times and always filled the syringes correctly, and after filling the injector indicated to check that there were no bubbles in the syringes.
Patient Sequence No: 1, Text Type: N, H10
[40342002]
The customer reports one patient (male) was injected with approximately 80 cm3 of air in ventricle. Additionally used were a prefilled syringe optiray ultraject 320 mg/ml, 125 ml and saline solution loaded in a empty syringe ref. 800096, lot c022097u. The person who attended the patient during injection did not know how this air was injected. The physician caring for the patient confirmed: the patient felt bad after the examination, with pain on thorax and dyspnea, due to it, the air in ventricle was discover in the scan. Electrocardiogram was normal, the patient was under observation for 2-3 hours, the pain and dyspnea disappeared. He was under observation for 1/2 day just as precaution. No other consequences to the patient. The patient was recover without any impact on his health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2016-00016 |
| MDR Report Key | 5500761 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-15 |
| Date of Report | 2016-02-18 |
| Date of Event | 2016-02-18 |
| Date Mfgr Received | 2016-02-19 |
| Device Manufacturer Date | 2012-08-31 |
| Date Added to Maude | 2016-03-15 |
| 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 | 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 | INJ. OPTIV DH,SI W/OEM |
| Generic Name | INJ. OPTIV DH,SI W/OEM |
| Product Code | IZQ |
| Date Received | 2016-03-15 |
| Model Number | INJ. OPTIV DH,SI W/OEM |
| Catalog Number | 844005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2016-03-15 |