MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-02-14 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[3377821]
It was reported that during prime of the device for a cardiopulmonary bypass procedure, the clip of hematocrit saturation (hct/sat) probe from the blood parameter monitoring (bpm) system had been broken off. Per the clinical review: the user reported that the hsat probe of the bpm system could not be clipped or secured to the disposable cuvette. Some troubleshooting was done and this did delay the preparation time of the cpb circuit, but likely did not delay the start of the surgical procedure. The device was not changed out, as the perfusionist used arterial blood gas for blood parameter monitoring. The surgical procedure was completed successfully, and there was no blood loss or no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[10680487]
Investigation in progress, but not yet completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2013-00173 |
| MDR Report Key | 3004384 |
| Report Source | 01,07 |
| Date Received | 2013-02-14 |
| Date of Report | 2013-01-22 |
| Date of Event | 2012-03-09 |
| Date Mfgr Received | 2013-01-22 |
| Date Added to Maude | 2013-04-02 |
| 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 |
| 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 100 MONITOR |
| Product Code | DTY |
| Date Received | 2013-02-14 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-02-14 |