MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-10 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[3069772]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the monitor's battery was found to be leaking and battery failure occurred. As a result, an alternate device was employed and the suspect unit was taken out of service. The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the pt. There was no reported adverse event to the end user as well.
Patient Sequence No: 1, Text Type: D, B5
[10249901]
The unit was taken out of service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2012-01303 |
| MDR Report Key | 2787490 |
| Report Source | 05,06 |
| Date Received | 2012-10-10 |
| Date of Report | 2012-09-13 |
| Date of Event | 2012-09-13 |
| Date Mfgr Received | 2012-09-13 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2013-01-16 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIPP DURBIN |
| 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 | 2012-10-10 |
| Model Number | 100 |
| Catalog Number | 100 |
| 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 SYSTEMS CORP. |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-10 |