MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-04-04 for TERUMO CDI 101 MONITOR manufactured by Terumo Cardiovascular System Corp..
[2578315]
During preparation of the device for a cardiopulmonary bypass procedure, the user reported that the blood parameter monitor readings were inaccurate. As a result, an alternate device was employed. The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the pt. Investigation in process, but not yet completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2012-00285 |
| MDR Report Key | 2519754 |
| Report Source | 07 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-03-12 |
| Date of Event | 2012-03-12 |
| Date Mfgr Received | 2012-03-12 |
| Date Added to Maude | 2012-08-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DOUGLAS FORTUNATO |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO CDI 101 MONITOR |
| Product Code | DTY |
| Date Received | 2012-04-04 |
| Model Number | 101 |
| Catalog Number | 101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEM CORP. |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-04 |