MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-10 for CDI BLOOD PARAMETER MONITORING SYSTEM 500 500AHCT manufactured by Terumo Cardiovascular Systems Corporation.
[145624692]
Evaluation is in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
[145624693]
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the values displayed on the blood parameter monitor (bpm) were unstable. The hemoglobin (hgb) and hematocrit (hct) were drifting in value. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per clinical review: the perfusion team had an incident with their bpm during a cpb procedure on (b)(6) 2019. The bpm turned on and passed color chip test without issue. During the procedure, after the first in-vivo calibration, the hct value was going up and down at a quick rate for no apparent reason, and then the bpm went to all dashes on the hct reading. The team opted to perform another in-vivo recalibration, and the value being reported on the blood gas was 25%. The team exchanged the unit with another unit, and continued the case without issue. This incident did not delay the surgical procedure. There was no blood loss or harm associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2019-00237 |
| MDR Report Key | 8599025 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-10 |
| Date of Report | 2019-08-02 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-07-31 |
| Device Manufacturer Date | 2000-06-02 |
| Date Added to Maude | 2019-05-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DOUGLAS PATTON |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1828100-11/08/2011-026-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
| Generic Name | MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500 |
| Product Code | DRY |
| Date Received | 2019-05-10 |
| Returned To Mfg | 2019-05-06 |
| Model Number | 500AHCT |
| Catalog Number | 500AHCT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |