MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-29 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp.
[3419501]
After use of the device for a cardiopulmonary bypass procedure, the user reported the hematocrit saturation (h/sat) cable was fractured. There were no reported adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[10878851]
Evaluation is in progress, but not yet concluded. Upon evaluation at the manufacturer. Found severe damage to the cable. Internal wires are broken and conductors are exposed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2013-00476 |
| MDR Report Key | 3098880 |
| Report Source | 05,06 |
| Date Received | 2013-04-29 |
| Date of Report | 2013-04-04 |
| Date of Event | 2013-04-01 |
| Date Mfgr Received | 2013-04-04 |
| Date Added to Maude | 2013-07-02 |
| 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 | TOM MYERS |
| 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 | 2013-04-29 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-04-29 |