MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-10 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.110 manufactured by International Technidyne Corp..
[1288283]
Healthcare professional reports inconsistent patient reports. Initial act result obtained of 345 seconds. Bolus of heparin administered (amount not reported) followed by retest 15 minutes later. Act test aborted when device reached 745 seconds and was still reading. Subsequent act result of 364 seconds was obtained. A fourth test was conducted generating an act result in the range of 700 seconds. The next two retests were both in the 300 seconds range. Healthcare professional reports a target range of 450 seconds. No report of adverse event, serious injury, or intervention.
Patient Sequence No: 1, Text Type: D, B5
[8456577]
(b)(4). Device manufacturer obtaining additional information about event from healthcare professional.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2010-00022 |
| MDR Report Key | 1628964 |
| Report Source | 05,06 |
| Date Received | 2010-03-10 |
| Date of Report | 2010-03-09 |
| Date Mfgr Received | 2010-02-09 |
| Date Added to Maude | 2010-08-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE PICCIANO |
| Manufacturer Street | 8 OLSEN AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 7325485700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON RESPONSE COAGULATION SYSTEM |
| Generic Name | RESPONSE INSTRUMENT |
| Product Code | KQG |
| Date Received | 2010-03-10 |
| Model Number | HRS.110 |
| Catalog Number | HRS.110 |
| Lot Number | UNK |
| 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 | 2010-03-10 |