MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-01-11 for HEMOCHRON JR HE-JR manufactured by International Technidyne Corp..
[42983]
The user facility has suggested that 148 days prior to notification the instrument produced inaccurate readings "in some instances", which may have resulted in improper administration of anticoagulant to this pt which, in turn, may have contributed to bleeding in a very high risk pt. Despite requests, no further info regarding this event has been received and co is unable to clarify the relationship, if any, of this event and the instrument or the appropriateness of the use of this instrument in this particular setting. The reports provided by this user-facility are the only ones related to misadministration of anticoagulant and possible bleeding using the instrument. The mfr will continue to seek clarification of the event and provide follow-up as appropriate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248721-1996-00004 |
| MDR Report Key | 63794 |
| Report Source | 05,06 |
| Date Received | 1997-01-11 |
| Date of Report | 1997-01-10 |
| Date of Event | 1996-06-11 |
| Date Mfgr Received | 1996-12-12 |
| Date Added to Maude | 1997-01-24 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR |
| Generic Name | POINT-OF-CARE ACT TESTER |
| Product Code | KQG |
| Date Received | 1997-01-11 |
| Model Number | HEMOCHRON JR |
| Catalog Number | HE-JR |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 63951 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | 6 OLSEN AVE EDISON NJ 08820 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-11 |