MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-10-20 for TERUMO CDI 101 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[4980967]
It was reported that during set-up of the device for a procedure, there were drifting hematocrit (hct) values. There was no patient involvement. No other details regarding the nature of this event were provided.
Patient Sequence No: 1, Text Type: D, B5
[12479019]
The reported complaint was not verifiable. This device is no longer marketed in the united states. This event occurred in (b)(6). The device will not be returned to the manufacturer for further evaluation and can not be analyzed to determine the failure mode. 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 | 1828100-2014-00870 |
| MDR Report Key | 4196947 |
| Report Source | 01,07 |
| Date Received | 2014-10-20 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-09 |
| Date Mfgr Received | 2014-09-26 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2014-11-03 |
| 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 |
| 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 | 7366634145 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO CDI 101 MONITOR |
| Generic Name | CDI 101 (7101) INTERFACE MODEL |
| Product Code | DTY |
| Date Received | 2014-10-20 |
| Model Number | 101 |
| Catalog Number | 101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-10-20 |