MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-21 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[3390776]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the battery melted to the back of the enclosure. The device was not changed out. The surgical procedure was completed successfully, and there was no blood loss and no adverse consequences to the patient. Per the clinical review: issue with "powering up" the cdi100 monitor during set-up for a procedure. The issue was not able to be resolved and the user did not use the device. This delayed the set-up time, but did not delay the start or actual surgical procedure. The perfusionist used an independent laboratory analyzer for intermittent sampling to guide clinical maneuvers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2013-00232 |
| MDR Report Key | 2998873 |
| Report Source | 05,06 |
| Date Received | 2013-02-21 |
| Date of Report | 2013-01-30 |
| Date of Event | 2013-01-29 |
| Date Mfgr Received | 2013-01-30 |
| Device Manufacturer Date | 2002-09-01 |
| 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 |
| 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 |
| Manufacturer G1 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Street | 6200 JACKSON RD. |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48103 |
| 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 | 2013-02-21 |
| 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 | 6200 JACKSON RD. ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-21 |