MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-25 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[16988207]
It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) was not accurate. This issue has occurred a couple of times and exact dates are unk by customer. The device was not changed out, as the customer used a lab analyzer to finish the case. The surgical procedure was completed successfully. There were no delays, no blood loss, or no adverse consequences to the pt. Per the clinical review on (b)(6) 2014: after consultation with the clinical team, it was discovered that the clip on the h/sat probe was broken and the security of the probe to the cuvette was not ideal. This would at times lead to inaccurate data (both hematocrit and saturation). This was found by the perfusionist and the data was not used to clinically manage the pt. Add'l lab samples were taken to better monitor and manage these values. The case was completed successfully, without delay and without associated blood loss.
Patient Sequence No: 1, Text Type: D, B5
[17081126]
Eval is in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2014-00542 |
| MDR Report Key | 3966259 |
| Report Source | 05,06 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-02 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-06-02 |
| Date Added to Maude | 2014-08-14 |
| 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 | 2014-06-25 |
| Returned To Mfg | 2014-06-17 |
| 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 | 2014-06-25 |