MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-17 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[2688272]
It was reported that during preparation of the device for a cardiopulmonary bypass procedure, that the battery has a physical crack in it with residue. The monitor was displaying a "replace battery" message also. As a result, an alternate device was employed. The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[9822885]
The reported complaint was confirmed. The customer replaced the battery and returned the old battery to the manufacturer for disposal. No additional action will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2012-00313 |
| MDR Report Key | 2547943 |
| Report Source | 05,06 |
| Date Received | 2012-04-17 |
| Date of Report | 2012-03-23 |
| Date of Event | 2012-03-23 |
| Date Mfgr Received | 2012-03-23 |
| Date Added to Maude | 2012-08-03 |
| 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 | 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 | 2012-04-17 |
| Returned To Mfg | 2012-03-29 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-04-17 |