MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-27 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular System Corp.
[18361647]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the monitor display blanked out intermittently. 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 pt.
Patient Sequence No: 1, Text Type: D, B5
[18402352]
This complaint was confirmed. During the investigator's review on (b)(4) 2014, a cracked battery was found inside the unit. Battery fluid had leaked out of the battery into the unit, damaging the circuits and also present on the circuit board. Battery acid is conductive and can create short circuit conditions and is considered to have caused the system shut down seen by the customer. The unit has been forwarded to the service department for disposition. If additional information 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 | 1828100-2014-00053 |
| MDR Report Key | 3744358 |
| Report Source | 05,06 |
| Date Received | 2014-01-27 |
| Date of Report | 2014-01-23 |
| Date of Event | 2013-08-13 |
| Date Mfgr Received | 2014-01-23 |
| Date Added to Maude | 2014-05-07 |
| 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 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 |
| Generic Name | CDI 100 |
| Product Code | DTY |
| Date Received | 2014-01-27 |
| Returned To Mfg | 2014-01-22 |
| 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 SYSTEM CORP |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-27 |