MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for AVANTA FLUID MANAGEMENT SYSTEM 58746413 AVA 500 PEDL manufactured by Bayer Medical Care Inc..
[188650332]
A system service check of the avanta fluid management system, serial number 10031, was completed on march 25, 2020 which confirmed that the injector was operating within bayer specifications. The customer discarded the suspect disposables at the time of the incident however, they were able to provide a lot number for the single-patient disposable set (spat). The testing of a retain sample is pending. Once the evaluation is completed, a follow-up report will be submitted. The offer of additional applications training has been accepted by the customer and will be scheduled.
Patient Sequence No: 1, Text Type: N, H10
[188650333]
On march 23, 2020, we received a report from our distributor that an adverse event had occurred. A (b)(6) year old male patient was undergoing a coronary angiogram and angioplasty for non-stemi acute coronary syndrome (acs). During the procedure, the patient purportedly suffered an air injection while connected to the avanta fluid management system. Upon review of the images, the physician observed an undisclosed amount of air within the left anterior descending (lad) artery. The patient's blood pressure began to drop at which time the physician administered 1mg of atropine and initiated a dopamine infusion after which the patient was reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520313-2020-00017 |
| MDR Report Key | 9897534 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2015-02-14 |
| Date Added to Maude | 2020-03-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE ECKERT |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 9408677 |
| Manufacturer G1 | BAYER MEDICAL CARE INC. |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVANTA FLUID MANAGEMENT SYSTEM |
| Generic Name | ANGIOGRAPHIC INJECTOR |
| Product Code | DXT |
| Date Received | 2020-03-30 |
| Model Number | 58746413 |
| Catalog Number | AVA 500 PEDL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER MEDICAL CARE INC. |
| Manufacturer Address | 1 BAYER DRIVE INDIANOLA, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |