MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-15 for TERUMO CARDIOVASCULAR PROCEDURE KIT 60045 manufactured by Terumo Cardiovascular Systems Corporation.
[145236376]
Device evaluation anticipated, but not yet begun. The sample photograph was received confirming the reported issue. It is anticipated that the actual sample will be returned for decontamination and further testing. The device history record (dhr) was reviewed and there were no issues noted. Additionally the ops valve coc indicated the component was deemed conforming by the supplier. All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up. The case label gtin: (b)(4), the production identifier are (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145236397]
The customer reported a leak in the over pressure safety (ops) valve. The customer had cut this ops valve into a suction line in order to convert it to vent line for aortic valve surgery. The valve leaked during the cardiopulmonary bypass surgery resulting in approximately 5 ml blood loss. The valve was changed out and there was no delay. Surgery was successfully completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1212122-2019-00006 |
| MDR Report Key | 8613101 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-15 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-07-16 |
| Device Manufacturer Date | 2018-01-16 |
| Date Added to Maude | 2019-05-15 |
| 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 | MS. KIM MEJIA |
| Manufacturer Street | 28 HOWE STREET |
| Manufacturer City | ASHLAND MA 01721 |
| Manufacturer Country | US |
| Manufacturer Postal | 01721 |
| Manufacturer Phone | 5082312454 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO CARDIOVASCULAR PROCEDURE KIT |
| Generic Name | CARDIOVASCULAR PROCEDURE KIT- CONVENIENCE TUBING PACK |
| Product Code | OEZ |
| Date Received | 2019-05-15 |
| Model Number | 60045 |
| Catalog Number | 60045 |
| Lot Number | WA15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 28 HOWE STREET ASHLAND MA 01721 US 01721 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |