MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-06-12 for HEMOCHRON JR MICROCOAGULATION ACT PLUS TEST JACT+ manufactured by International Technidyne Corp..
[5868574]
Healthcare professional reported out of range high readings with a hemochron signature elite and act plus sys. Pt of unspecified age, gender and weight was receiving iv heparin while undergoing a bypass procedure in the cardiovascular operating room. The target act was >480 seconds. The hemochron signature elite and act plus system reported for consecutive act results that were out of range high (>1005 seconds) following and iv bolus dose of heparin. The case continued and a subsequent act measured with a different reagent cuvette lot was 440 seconds after another iv bolus dose of heparin. The procedure was completed successfully and no pt injury or adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
[13370529]
(b)(4). The serial number of the hemochron signature elite instruments used during this procedure is (b)(4). Method: no ncr or other anomalies related to the complaint were identified. No trends or capas specific to this reagent cuvette lot.
Patient Sequence No: 1, Text Type: N, H10
[77848917]
Mdr follow-up #1 references itc complaint number (b)(4), and summarizes the results of lsr-027 that evaluated a device from the same lot of jact+ cuvettes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2015-00048 |
| MDR Report Key | 4848156 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-06-12 |
| Date of Report | 2015-05-14 |
| Date of Event | 2015-05-14 |
| Date Mfgr Received | 2015-05-14 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-06-29 |
| 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 |
| 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 |
| Generic Name | TEST, TIME, ACTIVATED CLOTTING TIME |
| Product Code | JBP |
| Date Received | 2015-06-12 |
| Model Number | JACT+ |
| Catalog Number | JACT+ |
| Lot Number | D5JAC111 |
| Device Expiration Date | 2016-07-01 |
| 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 | 2015-06-12 |