MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-13 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[19393313]
This complaint was confirmed by lab inspection. The unit's battery was cracked and leaking internal fluid leading to the corrosion of the battery compartment. According to the analysis, this prevented the unit from starting up. The unit would start when associated power supply was used, with all monitor functions working to specification. Service and replacement parts are no longer available. No add'l action will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[19482152]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the monitor would shut down unit. The device was not changed out, as the customer ran the case without hematocrit saturation module (h/sat). The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2013-00877 |
| MDR Report Key | 3396422 |
| Report Source | 05,06 |
| Date Received | 2013-09-13 |
| Date of Report | 2013-09-11 |
| Date of Event | 2013-04-08 |
| Date Mfgr Received | 2013-09-11 |
| Date Added to Maude | 2013-12-18 |
| 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 |
| 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 | 2013-09-13 |
| Returned To Mfg | 2013-05-13 |
| Model Number | 100 |
| Catalog Number | 100 |
| 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 CORP. |
| Manufacturer Address | 6200 JACKSON RD. ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-13 |