MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-01-12 for HEMOCHRON JR. HE-JR. manufactured by Itc.
[72521]
The user facility in the medwatch of 11/25/97 reported that while monitoring a pt on heparin using the hemochron jr. Act the pt subsequently developed nose and penile bleed. From co's records co has been able to determine that the hemochron jr. Test in question is the act-lr. In summary, the event, as conveyed to co's technical services, revealed act-lr values performed on this pt which were consistent with the level of heparinization administrated to this pt. Co immediately informed the user facility of these findings and identified the consistency of act-lr result with laboratory aptt values reported for this pt. Co also referenced the package insert instructions demonstrating act-lr and heparin concentration relationship. The user facility was advised to assess their heparin infusion guidelines. Based on co's review there is no causation between the hemochron jr. Act-lr and the pt's clinical bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248721-1997-00001 |
| MDR Report Key | 144087 |
| Report Source | 05,06 |
| Date Received | 1998-01-12 |
| Date of Report | 1998-01-09 |
| Date of Event | 1997-11-16 |
| Date Mfgr Received | 1997-12-11 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1998-01-16 |
| 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 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR. |
| Generic Name | POINT-OF-CARE ACT |
| Product Code | GFO |
| Date Received | 1998-01-12 |
| Model Number | HEMOCHRON JR. |
| Catalog Number | HE-JR. |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 134401 |
| Manufacturer | ITC |
| Manufacturer Address | 6 OLSEN AVENUE EDISON NJ 08820 US |
| Baseline Brand Name | HEMOCHRON JR. |
| Baseline Generic Name | POINT-OF-CARE ACT |
| Baseline Model No | HEMOCHRON JR. |
| Baseline Catalog No | HE-JR. |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-12 |