MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-07-30 for * HEMOCHRON 8000 HE8000 manufactured by International Technidyne Corp..
[245150]
The user, med ctr, reported problems with act test results. No documented adverse event was started by the user. The mfr (itc) has been in close contact with med ctr during the course of these events conveyed in their letter and has conducted a thorough eval of the suspect instruments and disposable test units. Though the co's investigations has determined that no product failure has occurred which could contribute to, or cause a pt injury, the co is submitting this report only as a follow-up to the med ctr user report submitted to the co and to the fda medical products reporting program. Hemochron instruments were initially returned to itc in 03/2001, with a report of mechanical problems and discrepant results characterized as "short clotting times". Upon receipt, mechanical, electrical and functional investigation of the units, including simulated use testing was conducted in an effort to identify discrepant activated clotting time values. The first instrument was found to have a loose cable assembly, which caused the wells to malfunction. No observable problems were found with the second device. Following the co's march investigation and repair, the units were returned to the customer. The instruments were subsequently returned to itc in 05/2001 for problems related to "abnormally short clotting times", as stated by the customer. At this time, new instruments were sent to the customer, each having successfully completed an in-depth linearity study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248721-2001-00001 |
| MDR Report Key | 345113 |
| Report Source | 06 |
| Date Received | 2001-07-30 |
| Date of Report | 2001-07-20 |
| Date of Event | 2001-05-01 |
| Date Mfgr Received | 2001-06-29 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 2001-08-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN CLAY |
| Manufacturer Street | 6 OLSEN AVE |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 7325485700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | WHOLE BLOOD COAGULATION INSTRUMENT |
| Product Code | KQG |
| Date Received | 2001-07-30 |
| Model Number | HEMOCHRON 8000 |
| Catalog Number | HE8000 |
| Lot Number | NA |
| ID Number | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 334445 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | 6 OLSEN AVE. EDISON NJ 08820 US |
| Baseline Brand Name | HOMOCHRON 8000 |
| Baseline Generic Name | WHOLE BLOOD COAGULATION SYSTEM |
| Baseline Model No | HEMOCHRON 8000 |
| Baseline Catalog No | HE8000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-30 |