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 2015-06-11 for HEMOCHRON JR. MICROCOAGULATION ACT PLUS TEST JACT+ manufactured by International Technidyne Corp..
[5944812]
Healthcare professional reported excessive bleeding while using hemochron signature elite and act+ system to monitor anticoagulation status using intravenous heparin during a procedure. An (b)(6) kg pt of unspecified age and gender was undergoing a vascular procedure on an unspecified leg. Over the course of the procedure that lasted more than 3 hrs, act+ test results increased accordingly during incremental heparin dosing. Near the end of the procedure excessive bleeding occurred, initially treated with fresh frozen plasma and finally protamine to reverse the effects of heparin. The act result fell to normal levels and bleeding was controlled. No serious adverse events or other medical complications were reported. Both electronic and liquid quality control testing passed prior to the procedure. System malfunction is not suspected.
Patient Sequence No: 1, Text Type: D, B5
[13485819]
This mdr submitted on 06/10/2015 references itc complaint #(b)(4). The associated homochron signature elite instrument used during the procedure is referenced by itc complaint #(b)(4). The most likely cause for this patient's bleeding was the administration of an excessive amount of heparin. This may have been compounded by an undocumented anti-thrombin-iii deficiency. The use of this jact+ test, which is not optimized for low heparin concentrations, may have contributed to how the anticoagulation management was conducted during the procedure. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[76161842]
Mdr follow-up #1 references (b)(4), and summarizes the results of lsr-030 that evaluated a device from the same lot of jact+ cuvettes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2015-00045 |
| MDR Report Key | 4843723 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-06-11 |
| Date of Report | 2015-05-19 |
| Date of Event | 2015-05-19 |
| Date Mfgr Received | 2015-05-19 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-06-16 |
| 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 | 2015-06-11 |
| Model Number | JACT+ |
| Catalog Number | JACT+ |
| Lot Number | D5JAC089 |
| 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 | 1. Other | 2015-06-11 |