MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-15 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[17952827]
It was reported that during use of the device for a cardiopulmonary bypass procedure, the hematocrit readings were not stable. 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 patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2013-01010 |
| MDR Report Key | 3658007 |
| Report Source | 05,06 |
| Date Received | 2013-11-15 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-10-22 |
| Date Mfgr Received | 2013-10-24 |
| Date Added to Maude | 2014-04-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAN WINDER |
| Manufacturer Street | 6200 JACKSON RD. |
| 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 100 MONITOR |
| Product Code | DTY |
| Date Received | 2013-11-15 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-15 |