N
Patient 1
INITIAL MDR SUBMISSION. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED THE SAMPLE FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).
MAUDE MDR 6837524
- MDR report key
- 6837524
- Report number
- 3010838917-2017-00037
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-22
- Date received
- 2017-09-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MINDY FABER
- Address
- 26125 NORTH RIVERWOODS BLVD. METTAWA IL 60045 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CABLE, IBP, SINGLE, ARGON, 3.6 M | DISPLAY, CATHODE-RAY TUBE, MEDICAL | VYAIRE MEDICAL, INC | DXJ | 2016995-001 | 201503K | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-09-01 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE PATIENT WAS IN ICU AND HIS INVBP VALUES DROPPED DOWN UNEXPECTEDLY. THE PATIENT HAS GOT NORADRENALIN AND HIS INVASIVE BP WAS MONITORED. WHEN THE VALUES DROPPED DOWN THE PATIENT GOT MORE NORADRENALIN BUT THERE WASN?T ANY RESPONSE TO THAT. BP CURVE WAS CLEAR ALL THE TIME. THEN THE BP RESET TO ZERO AND AFTER THAT THE VALUES WERE HIGH. THEN NORADRENALIN INFUSION WAS DECREASED. AND EVEN IF SUPPORT MEDICATION WAS DECREASED THE BP VALUES WERE INCREASED. INFUSION SET AND CABLE WAS DETACHED FROM ONE ANOTHER AND BP WAS RESET TO ZERO. AFTER THAT THE BP VALUES WERE NORMAL FOR A WHILE BUT THEN ROSE AGAIN. FINALLY CABLE WAS CHANGED TO A NEW ONE AND AFTER THAT THE VALUES WERE STABLE. PATIENT WAS IN SLEEP ALL THE TIME AND HIS STATUS WAS STABLE. BECAUSE OF THAT ABNORMAL FLUCTUATIONS IN INVBP VALUES WERE STRANGE. INCREASED BP WOULD BE DANGEROUS FOR THIS PATIENT. THE INVBP VALUES WERE NOT RELIABLE AND IT WAS IMPOSSIBLE TO KNOW THE REAL INV BP. INTERVENTION: MORE NORADRENALIN GIVEN BASED ON INV BP READINGS.