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 RESPONSE INSTRUMENT HRS.110 manufactured by Accriva Diagnostics.
[120106406]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron response instrument, serial number (b)(4). This mdr captures the child case (complaint (b)(4)) for the lot number of the hemochron flip top p214 act tubes used during the procedure. Method codes: device not returned. Process evaluation performed. Dhf review shows instrument repair in (b)(6) 2014 with replacement of test wells, battery, cpu and printer. No ncs. 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. This is the initial 30-day report that precedes the instrument evaluation. Mdr follow-up #1 will be submitted if the device is returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[120106407]
A healthcare professional reported discrepant act results with a different hemochron response (serial number (b)(4)) and low-range act tube-based coagulometer during a vascular surgical procedure on a (b)(6) infant with unspecified identity, age and gender. The target act for this procedure was >200 seconds. Following an intravenous 40 unit/kg heparin dose, the act result was reported as 145 seconds, which was a lower than expected result. A repeat blood sample was drawn 5 minutes later and was reported as 45 seconds, which was also a lower than expected result. An additional 15 units/kg of intravenous heparin was given and the act was measured on the hemochron response instrument named in this complaint (serial number (b)(4)) 25 minutes later. The act result was reported as 143 seconds, which was also a lower than expected result. The procedure was completed successfully. Both electronic and liquid quality controls passed prior to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00020 |
| MDR Report Key | 7871419 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2014-04-18 |
| 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 RESPONSE INSTRUMENT |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-09-12 |
| Returned To Mfg | 2018-08-21 |
| Model Number | HRS.110 |
| Catalog Number | HRS.110 |
| 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 | 2018-09-12 |