MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-22 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[4549237]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the hematocrit (hct)/ oxygen (o2) saturation monitoring display would go out after less than five minutes. The user would turn the unit off and plug it in, but it would still only run for less than five minutes. The device was not changed out, as the unit was not used for 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
[11795080]
This has been going on for a while. Exact dates were not documented by the customer. Upon receipt of the unit, it was noted that a cracked battery was in the unit and caused an intermittent failure due to battery acid leaking into the unit. This issue makes this complaint now reportable. A cracked battery was found that had leaked internal fluid. The battery leaking was confirmed to have reached the printed circuit board assembly (pcba). Battery acid has damaged the circuits and was present on the circuit board (acid is conductive and can create short circuit conditions) and is considered to have caused the blanking out issue. If additional 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 | 1828100-2014-00041 |
| MDR Report Key | 3747718 |
| Report Source | 05,06 |
| Date Received | 2014-01-22 |
| Date of Report | 2014-01-16 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2014-01-21 |
| 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 | 2014-01-22 |
| Returned To Mfg | 2014-01-16 |
| 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 | 2014-01-22 |