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..
[20154984]
Healthcare professional reported results using a hemochron signature elite microcoagulation act plus system that were out of range high in a (b)(6) male patient undergoing a cardiovascular bypass procedure. Anticoagulation with iv heparin was administered with a target act range of 440 to 520 seconds. Act results were as expected as additional heparin doses were given. In the final three hours of the 11 hour procedure, test results reported with the hemochron signature elite and act plus system were highly variable. Five out of range high results were reported, two of which were confirmed by running act plus reagent cuvettes from the same lot on a second hemochron signature elite instrument. Three act results that were lower than expected were also reported during this three hour time period. The procedure was completed successfully and no patient injury or adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
[20462685]
Reference itc complaint number (b)(4) for the out of range high act result and itc complaint number (b)(4) for the lower than expected act results. The serial numbers of the associated hemochron signature elite instruments used during this case ((b)(4)) are referenced by itc complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66332567]
This mdr follow up #1 references itc complaint number (b)(4) and provides the result of css-lsr number (b)(4)reported on 11/12/2015. Testing was performed using an adjacent lot of jact + (d5jac086) because lot d5jac085 in questin was consumed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2015-00046 |
| MDR Report Key | 4844592 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-06-11 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-04-30 |
| Date Mfgr Received | 2015-11-12 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-06-25 |
| 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 AVENUE |
| 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 | D5FAC085 |
| 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 | 2015-06-11 |