MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-10 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[5489114]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) took a long time to power up. The device was not changed out, as they used the bpm for the case. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[12887002]
This complaint is related to mdr# 1828100-2015-00132. This has been an ongoing issue for the past three months. The reported complaint was confirmed. During inspection of the bpm, it was found to have a damaged battery and battery acid had leaked into the unit effecting the unit to power on. 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 | 1828100-2015-00133 |
| MDR Report Key | 4511465 |
| Report Source | 05,06 |
| Date Received | 2015-02-10 |
| Date of Report | 2015-02-06 |
| Date Mfgr Received | 2015-02-06 |
| Date Added to Maude | 2015-03-16 |
| 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 | 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 | 2015-02-10 |
| Returned To Mfg | 2015-02-03 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-02-10 |