MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-10 for HEMOCHRON RESPONSE SYSTEM HRS.110 manufactured by International Technidyne Corp..
[1503925]
Erratic result reported over time when no further heparin administered: post-bolus (time-to-test not reported) 445 seconds; 10 minutes post bolus - 279 seconds; 30 minutes post bolus - 442 seconds; 10 minutes post bolus - 398 seconds. Procedure, therapeutic range, and act baseline not reported. No report of adverse event, serious injury, or intervention.
Patient Sequence No: 1, Text Type: D, B5
[8653505]
Itc complaint (b)(4). Manufacturer evaluation / investigation pending add'l info from consumer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2009-00404 |
| MDR Report Key | 1711837 |
| Report Source | 05 |
| Date Received | 2009-09-10 |
| Date of Report | 2009-08-27 |
| Date of Event | 2007-05-24 |
| Date Mfgr Received | 2009-07-21 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2010-11-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID GRONSOTAJSKI |
| 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 SYSTEM |
| Generic Name | RESPONSE INST / TUBE TYPE NOT GIVEN |
| Product Code | KQG |
| Date Received | 2009-09-10 |
| 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 | 1. Other | 2009-09-10 |