MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-03 for HEMOCHRON JR. MICROCOAGULATION ACT PLUS TEST JACT+ manufactured by Accriva Diagnostics.
[25913657]
This mdr submitted on (b)(6) 2015 references accriva complaint number (b)(4). The serial number of the hemochron signature elite instrument used during this procedure and reported as a child under this mdr is (b)(4) and references accriva complaint number (b)(4). Method: actual device not evaluated. Process evaluation performed. No other ncrs or other anomalies related to the complaint were identified. Trend noted for the product but no trend for the lot in question. No capa. Results: no results available since no evaluation was performed. Conclusion: device not returned. The hemochron signature elite (serial number (b)(4)) used during this case was been returned for evaluation. Accruva has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[25913658]
Healthcare professional reported a lower than expected reading with a hemochron signature elite and act plus system. A (b)(6) male patient was receiving iv heparin during a 6-vessel cabg. The target act was greater than 400 seconds. The hemochron signature elite and act plus system reported an act result of 368 seconds, which was lower than expected. The perfusionist questioned the result and repeated the test on a second hemochron signature elite instrument (serial number (b)(4)) and the result was 434 seconds, which was as expected. The procedure was completed without adverse events. Whole blood samples were obtained from a flowing line on bypass and no waste was required, which is consistent with the instructions for use. Both electronic and liquid quality controls passed.
Patient Sequence No: 1, Text Type: D, B5
[73850971]
This mdr follow up #1 submitted on 10/20/2015. References accriva complaint number (b)(4). This report provides the results of 2015-css-047, which attempted to reproduce the customer complaint of inconsistent act results with this cuvette lot of jact+. Reserve sample from same lot, no failure detected. Whole blood samples from three normal donor were tested at final heparin concentrations of 0, 3. 3 and 5. 0 units/ml with 10 replicates.
Patient Sequence No: 1, Text Type: N, H10
[73850972]
Follow up #1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2015-00004 |
| MDR Report Key | 5060318 |
| Date Received | 2015-09-03 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-08-06 |
| Date Mfgr Received | 2015-10-19 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-09-08 |
| 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 DR |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582632490 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR. MICROCOAGULATION ACT PLUS TEST |
| Generic Name | TEST, TIME, ACTIVATED CLOTTING TIME |
| Product Code | JBP |
| Date Received | 2015-09-03 |
| Model Number | JACT+ |
| Catalog Number | JACT+ |
| Lot Number | F5JAC508 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSTICS |
| Manufacturer Address | SAN DIEGO CA 92128 US 92128 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-03 |