MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-08-12 for HEMOCHRON JR. MICROCOAGULATION ACT PLUS TEST JACT+ manufactured by Accriva Diagnostics.
[24944474]
This mdr submitted on 08/12/2015 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). Process evaluation of the hemochron signature elite instrument associated with this complaint was performed and no ncmrs or anomalies were identified. Accriva has requested all data required for form 3500a. Fields for which data were not obtainable or are not applicable are intentionally left blank.
Patient Sequence No: 1, Text Type: N, H10
[24944475]
Healthcare professional reported out of range high readings with a hemochron signature elite and act plus system. A (b)(6) male patient was receiving iv heparin while on cardiovascular bypass during an unspecified interventional cardiology procedure. The target act was not specified. The hemochron signature elite and act plus system reported one act result greater than 1005 seconds (out of range high). An act test was repeated immediately and the result was 506 seconds, which was as expected. The procedure continued and a subsequent act measured with the same hemochron signature elite and act plus system after protamine was administered was 136 seconds. The heparin doses administered and the act results reported during the case are summarized in section. Both electronic and liquid quality controls passed. The procedure was completed successfully and no patient injury or adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
[73855745]
This mdr follow-up #1 submitted on 10/22/2015. References accriva complaint number (b)(4). This report provides the results of lsr 15-048, which attempted to reproduce the customer complaint with this cuvette lot of jact+. Reserve sample tested from same lot, no failure detected. Whole blood samplers from three normal donors 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
[73855746]
Follow-up #1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2015-00002 |
| MDR Report Key | 5004129 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-08-12 |
| Date of Report | 2015-07-24 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-10-20 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-08-14 |
| 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 | 2015-08-12 |
| Model Number | JACT+ |
| Catalog Number | JACT+ |
| Lot Number | F5JAC540 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-08-12 |