MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-27 for HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM manufactured by Accriva Diagnostics.
[132387645]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite, serial number (b)(4). Accriva diagnostics has requested all data required for form 3500a. This is the initial 30-day report that precedes the instrument evaluation. Mdr 2250033-2018-00030 follow-up #1 will be submitted after the device is returned to the manufacturer and the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[132387646]
Healthcare professional reported that a hemochron signature elite and low-range act system reported higher than expected patient results during a coronary artery bypass graft and mitral valve repair. The patient was receiving intravenous heparin with a target act of 400+ seconds. After a bolus dose of heparin, a higher than expected act result was reported. The next act result was below the act target, which was unexpected low result, which when repeated was also below the act target. Additional heparin was administered and subsequent act results were as expected. The elite instrument in question passed liquid and electronic quality controls prior to the start of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00030 |
| MDR Report Key | 8201752 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-27 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-11-26 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2018-12-27 |
| 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 SRQUENCE 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 | 2018-12-27 |
| Returned To Mfg | 2019-01-09 |
| 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 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-27 |