MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-22 for TERUMO CDI 101 MONITOR 101TK manufactured by Terumo Cardiovascular Systems Corp..
[16437753]
It was reported that during use of the device for a cardiopulmonary bypass procedure, the unit was not giving accurate readings. The surgical procedure was completed successfully, and there was no blood loss and no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[16623710]
Date of the event - the date of the event was not provided. Date entered is estimated. This complaint could not be confirmed. The interface module (im) and hematocrit/oxygen saturation (hsat) probes used with the customer's system were not available for testing; therefore, a service test module and probe were used. A comparison between the monitor printout and the blood gas analysis (bga) printouts for 24 points was performed. Readings were within 2% hematocrit for all points. This report is being submitted to the fda as a result of a retrospective review of product complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2012-00581 |
| MDR Report Key | 2624284 |
| Report Source | 05,06 |
| Date Received | 2012-05-22 |
| Date of Report | 2009-01-28 |
| Date of Event | 2009-01-28 |
| Date Mfgr Received | 2009-01-28 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2012-08-06 |
| 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 | KIPP DURBIN |
| 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 101 MONITOR |
| Product Code | DTY |
| Date Received | 2012-05-22 |
| Returned To Mfg | 2009-03-03 |
| Model Number | 101TK |
| Catalog Number | 101TK |
| 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 | 2012-05-22 |