MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-02-02 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[19684366]
During cardiopulmonary bypass the monitoring device reported a hemtocrit of 22%. A sample measured by separate analytical means revealed a hemoglobin level of 3 gm/dl (approximately 10% hematocrit). After use, the device demonstrated normal calibration. Subsequent use in comparison to another similar device and an analytical lab results. There were no adverse consequences to the patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023117-2006-00002 |
| MDR Report Key | 672986 |
| Report Source | 01,07 |
| Date Received | 2006-02-02 |
| Date of Report | 2006-02-02 |
| Date of Event | 2006-01-03 |
| Date Mfgr Received | 2006-01-03 |
| Date Added to Maude | 2006-02-13 |
| 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 | 0 |
| Manufacturer Contact | STEVENS ARICK |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7347416238 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO CDI 100 MONITOR |
| Generic Name | BLOOD OXYGEN SATURATION MONITOR |
| Product Code | CCL |
| Date Received | 2006-02-02 |
| Model Number | 100 |
| Catalog Number | 100 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 662294 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | * TUSTIN CA 92780 US |
| Baseline Brand Name | TERUMO CDI 100 MONITOR |
| Baseline Generic Name | BLOOD OXYGEN SATURATION MONITOR |
| Baseline Model No | 100 |
| Baseline Catalog No | 100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-02 |