MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-02 for HEMOCHRON JR. MICROCOAGULATION LOW RANGE JACT-LR manufactured by International Technidyne Corp..
[27692886]
This mdr submitted on (b)(6) 2015 references itc complaint number (b)(4). The associated hemochron signature elite instrument associated with this complaint is se2864. Dhr review was performed. No ncr or any other anomalies related to the cuvette lot were identified. There is no trend for jact-lr or the cuvette lot in question. No related irs or capas. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[27692887]
Healthcare professional reported inconsistent pt results with a hemochron signature elite (se2864) and act-lr system. An (b)(6) male pt was receiving iv heparin during an ablation procedure to treat atrial fibrillation. The target act range was greater than 300 seconds. The hemochron signature elite and act-lr system reported an act result that was out of range high (oor-h), and the heparin infusion was stopped. After 2 sequential oor-h results were reported, the perfusionist began side by side testing with 2 other elite instruments. Abridged clinical data is summarized. Pt treatment was based upon the act results from instrument se9265. The procedure was completed without advers eevents. Electronic and liquid quality controls passed on all signature elite instruments utilized.
Patient Sequence No: 1, Text Type: D, B5
[75480630]
This mdr f/u 1 submitted 10/19/2015 references itc complaint number (b)(4). This report provides the results of lsr-045 which attempted to reproduce the complaint of inconsistent act results with this lot. Reserve sample tested from same lot, no failure detected. Whole blood samples from three normal donors were tested at final heparin concentrations of 0, 0. 075 and 1. 37 units/ml with 10 replicates.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2015-00052 |
| MDR Report Key | 5130889 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-02 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-09-04 |
| Date Mfgr Received | 2015-09-04 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-10-06 |
| 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 LOW RANGE |
| Generic Name | TEST, TIME, ACTIVATED CLOTTING TIME |
| Product Code | JBP |
| Date Received | 2015-10-02 |
| Model Number | JACT-LR |
| Catalog Number | JACT-LR |
| Lot Number | C5JLR042 |
| Device Expiration Date | 2016-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-10-02 |