MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for CIRQLATOR manufactured by Advanced Circulatory.
[23663686]
Icu patient, being treated for tbi, was being mechanically ventilated in the neuro icu. The patient suffered a desaturation event the previous day, which was attributed to a mucus plug. Patient was stable and placed on the device at 11:00 am ((b)(6) 2015). The airway pressure was unusually high and prompted several airway suctions. Airway pressure remained marginally high. Device was otherwise tolerated. Several hours into device use, fio2 was increased (to 60%) to compensate for a decrease in monitored arterial oxygen saturation (decreasing to 96%). Device was turned off after four hours of use. 60 minutes after the device was turned off, the patient suffered a desaturation, with sats reaching 70%. Patient was manually ventilated with 100% oxygen and emergency bronchoscopy was performed. A moderate amount of mucus was removed from the patient's left lung. After suctioning, the oxygen saturation returned to normal. The patient was returned to mechanical ventilation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2015-00002 |
| MDR Report Key | 5019418 |
| Date Received | 2015-08-20 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-08-20 |
| 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 | DIANE HOWELL |
| Manufacturer Street | 1905 COUNTY ROAD C |
| Manufacturer City | ROSEVILLE 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CIRQLATOR |
| Product Code | BWF |
| Date Received | 2015-08-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED CIRCULATORY |
| Manufacturer Address | 1905 COUNTY ROAD C ROSEVILLE MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-20 |