MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-07-15 for HEMOCHRON JR. MICROCOAGULATION ACT PLUS TEST JACT+ manufactured by International Technidyne Corp..
[17852815]
Healthcare professional reported out of range high readings with hemochron signaure elite and act plus system. A (b)(6) male patient was receiving iv heparin while on cardivascular bypass during an aortic valve repair procedure. The target act was 440-480 seconds. The hemochron signature elite and act plus system reported two consecutive act results that were out of range high (>1005 seconds). Times of adminisration and dosage of heparin were not specified. The case continued and a subsequent act measured with the sme hemochron signaure elite and act plus system was 379 seconds, which was below the target act range. Both electronic and liquid quality controls passed. The procedure was as focompleted sucessfully and no patient injury or adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
[18141247]
(b)(4). The serial number of the hemochron signature elite instrument used during this procedure is (b)(4). Assessment of (b)(4) concluded that it was unrelated to the complaint. No other ncrs or other anomalies related to the complaint were identified. No current lot or product trends. No capa. Despite multiple requests by itc for the heparin doses and timing of drug administration, the end user has refused to provide the requested information. Itc will continue following this complaint and will report a follow-up mdr if this information becomes available. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[37074575]
Follow-up #1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248721-2015-00050 |
| MDR Report Key | 4921005 |
| Report Source | 05,06 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-06-10 |
| Date Mfgr Received | 2015-06-17 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-07-23 |
| 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 | 8 OLSEN AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| 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 |
| Product Code | JBP |
| Date Received | 2015-07-15 |
| Model Number | JACT+ |
| Catalog Number | JACT+ |
| Lot Number | C5JAC817 |
| Device Expiration Date | 2016-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-15 |