MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-29 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp.
[3419501]
After use of the device for a cardiopulmonary bypass procedure, the user reported the hematocrit saturation (h/sat) cable was fractured. There were no reported adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[10878851]
Evaluation is in progress, but not yet concluded. Upon evaluation at the manufacturer. Found severe damage to the cable. Internal wires are broken and conductors are exposed.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1828100-2013-00476 |
MDR Report Key | 3098880 |
Report Source | 05,06 |
Date Received | 2013-04-29 |
Date of Report | 2013-04-04 |
Date of Event | 2013-04-01 |
Date Mfgr Received | 2013-04-04 |
Date Added to Maude | 2013-07-02 |
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 | TOM MYERS |
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 | 2013-04-29 |
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 | 2013-04-29 |