MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-03-14 for CDI BLOOD PARAMETER MONITORING SYSTEM 500 500AHCT manufactured by Terumo Cardiovascular Systems Corporation.
[138834589]
Evaluation is in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
[138834590]
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the user saw and smelled smoke from the unit when it was turned on. The unit was turned off and not used throughout the case. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2019-00127 |
| MDR Report Key | 8422039 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-14 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2019-03-14 |
| 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 | MR. DOUGLAS PATTON |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
| Generic Name | MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500 |
| Product Code | DRY |
| Date Received | 2019-03-14 |
| Returned To Mfg | 2019-03-11 |
| Model Number | 500AHCT |
| Catalog Number | 500AHCT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-14 |