MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2011-09-12 for TERUMO CDI 500 BLOOD PARAMETER MONITOR 500AHCT manufactured by Terumo Cardiovascular System Corp..
[2158797]
During preparation of the device for a cardiopulmonary bypass procedure, the user reported the unit failed calibration. The device was not changed out. The user reported the surgical procedure was completed successfully, and there were no adverse consequences to the pt as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9393651]
Eval in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2011-02726 |
| MDR Report Key | 2254862 |
| Report Source | 00,05,06 |
| Date Received | 2011-09-12 |
| Date of Report | 2011-09-12 |
| Date of Event | 2011-08-18 |
| Date Mfgr Received | 2011-08-18 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2011-10-25 |
| 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 | DOUGLAS FORTUNATO |
| 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 500 BLOOD PARAMETER MONITOR |
| Generic Name | ON LINE BLOOD GAS MONITOR |
| Product Code | EWO |
| Date Received | 2011-09-12 |
| Returned To Mfg | 2011-08-23 |
| Model Number | 500AHCT |
| Catalog Number | 500AHCT |
| 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 | 2011-09-12 |