AVANTA FLUID MANAGEMENT SYSTEM
Report
- Report Number
- 2520313-2025-00001
- Event Type
- Injury
- Date Received
- January 23, 2025
- Date of Event
- October 1, 2024
- Report Date
- February 6, 2025
- Manufacturer
- BAYER MEDICAL CARE INC
- Product Code
- DXT
- UDI-DI
- 00616258008578
- PMA / PMN Number
- K050456
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SYSTEM SERVICE CHECK REPORT OF THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SERIAL NUMBER (B)(6) ) HAS BEEN SCHEDULED. THE MEDRAD® SINGLE-PATIENT DISPOSABLE SET (SPAT, LOT NUMBER UNKNOWN) AND THE MULTI-PATIENT DISPOSABLE SET (MPAT, LOT NUMBER UNKNOWN) IN USE DURING THE INCIDENT WERE NOT SAVED. LOT NUMBERS FOR THE SUBJECT DISPOSABLES WERE NOT PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES IS NOT POSSIBLE. THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: "WARNING: EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBING, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT." THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MEDRAD® SINGLE-PATIENT DISPOSABLE SET (SPAT, LOT NUMBER UNKNOWN) AND THE MULTI-PATIENT DISPOSABLE SET (MPAT, LOT NUMBER UNKNOWN) IN USE DURING THE INCIDENT WERE NOT SAVED. LOT NUMBERS FOR THE SUBJECT DISPOSABLES WERE NOT PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES IS NOT POSSIBLE. THE OFFER OF ADDITIONAL APPLICATIONS TRAINING WAS ACCEPTED BY THE CUSTOMER AND WILL BE SCHEDULED THIS MONTH. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: "WARNING: EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBING, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT." THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
BAYER MEDICAL CARE INC. WAS INFORMED THAT A 60-YEAR-OLD MALE EXPERIENCED AN ALLEGED AIR INJECTION DURING A HEART CATHETERIZATION PROCEDURE WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED AFTER A CONTRAST INJECTION IN THE LEFT CORONARY SYSTEM. FOLLOWING THE EVENT, THE PATIENT WENT INTO CARDIAC ARREST, WAS IMMEDIATELY RESUSCITATED AND WAS SUCCESSFULLY STABILIZED. THE PATIENT IS REPORTED AS DOING WELL.
BAYER MEDICAL CARE INC. WAS INFORMED THAT A 60-YEAR-OLD MALE EXPERIENCED AN ALLEGED AIR INJECTION DURING A HEART CATHETERIZATION PROCEDURE WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED AFTER A CONTRAST INJECTION IN THE LEFT CORONARY SYSTEM. FOLLOWING THE EVENT, THE PATIENT WENT INTO CARDIAC ARREST, WAS IMMEDIATELY RESUSCITATED AND WAS SUCCESSFULLY STABILIZED. THE PATIENT IS REPORTED AS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489740 | AVANTA FLUID MANAGEMENT SYSTEM | ANGIOGRAPHIC INJECTOR | DXT | BAYER MEDICAL CARE INC | 60726742 | 00616258008578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Other | MULTI-PATIENT DISPOSABLE SET (MPAT).| MULTI-PATIENT DISPOSABLE SET (MPAT).| SINGLE-PATIENT DISPOSABLE SET (SPAT).| SINGLE-PATIENT DISPOSABLE SET (SPAT). |