MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-02 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp.
[15021142]
It was reported that during set-up the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) was not accurate. The device was not changed out, and unit was not used for the case. 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
[15470082]
The user facility's perfusionist stated this issue has been ongoing since (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2013-00879 |
| MDR Report Key | 3435262 |
| Report Source | 05,06 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-09-11 |
| Date of Event | 2013-05-01 |
| Date Mfgr Received | 2013-09-11 |
| Date Added to Maude | 2014-01-08 |
| 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 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 | 2013-10-02 |
| 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 | 2013-10-02 |