MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-04-07 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.RF manufactured by International Technidyne Corp..
[19462269]
Health care professional: reports the blood clotting time between the two test wells for hemochron response had a difference of over 60 seconds although the doctor used the sample blood sample per customer. Poor pt correlation. Pt was being monitored while on bypass, the targeted range for the pt was -350 sec.
Patient Sequence No: 1, Text Type: D, B5
[19753358]
(b)(4). Manufacturer awaiting medical device return from customer for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2010-00068 |
| MDR Report Key | 1657236 |
| Report Source | 05,08 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-04-07 |
| Date Mfgr Received | 2010-03-10 |
| Date Added to Maude | 2011-01-26 |
| 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 | HEMOCHRON RESPONSE COAGULATION ANALYZER |
| Product Code | KQG |
| Date Received | 2010-04-07 |
| Model Number | HRS.RF |
| Catalog Number | HRS.RF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-04-07 |