MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-12 for HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM manufactured by Accriva Diagnostics.
[120108383]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite instrument, serial number (b)(4). Accriva diagnostics' complaint number (b)(4) captures the hemochron act+ reagent cuvette lot used during the procedure, which is classified as a child case. Method codes: analysis of production records. Device not returned. Results code: no findings available. Conclusion code: conclusion not yet available. Accriva diagnostics has requested all data required for form 3500a. Fields for which data were not obtainable or are not applicable are intentionally left blank. An instrument evaluation is anticipated. Results of the evaluation will be submitted as mdr 2250033-2018-00021 follow-up #1.
Patient Sequence No: 1, Text Type: N, H10
[120108384]
A healthcare professional reported a lower than expected act result with a hemochron signature elite and act+ microcoagulation system during cardiovascular surgery. The signature elite named in this complaint was used during the procedure and act results recorded were as expected until the latter part of the procedure. An act result was 343 seconds, which was an expected result. However, the act result a short time later was recorded as 123 seconds, which was a lower than expected result. After a heparin bolus was administered, an act was assayed on a second hemochron signature elite and act+ system and was recorded as >850 seconds, which was higher than expected. Protamine was administered at the end of the procedure and no adverse events or medical complications were reported. Electronic and liquid qc passed before the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00021 |
| MDR Report Key | 7871423 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2015-02-27 |
| Date Added to Maude | 2018-09-12 |
| 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 | JON MCDERMED |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582632490 |
| Manufacturer G1 | ACCRIVA DIAGNOSTICS |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-09-12 |
| Returned To Mfg | 2018-08-09 |
| Model Number | ELITE |
| Catalog Number | ELITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSTICS |
| Manufacturer Address | 6260 SRQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-12 |