MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-11-09 for TERUMO CDI 100 MONITOR 5310 manufactured by Terumo Cardiovascular Systems Corp.
[3075512]
It was reported that during use of the device for a cardiopulmonary bypass procedure, smoke was observed coming from the unit's external power supply. The user discontinued use of the unit and used another model and brand of hematocrit and oxygen saturation monitoring. The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[10402216]
The customer will not be returning the unit for repair. If add'l info becomes available on this complaint that would alter the facts and/or conclusion a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2012-01412 |
| MDR Report Key | 2834847 |
| Report Source | 01,07 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-17 |
| Date of Event | 2012-09-27 |
| Date Mfgr Received | 2012-10-17 |
| Date Added to Maude | 2013-02-15 |
| 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 | KIPP DURBIN |
| 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 100 MONITOR |
| Product Code | DTY |
| Date Received | 2012-11-09 |
| Model Number | 5310 |
| Catalog Number | 5310 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-11-09 |