MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-06 for HEMOCHRON JR. manufactured by Internation Technidyne Corp..
[17782]
Pt undergoing a stent procedure in the catheterization laboratory was given a bolus of heparin before being released to cardiac intensive care unit for follow-up. The activated clotting time was 295 seconds by the instrument used in cath lab. Using a new system for act's, the hemochron device, the simultaneously performed act was 189. The discrepancy caused personnel to repeat the activated clotting time using both devices 30 minutes later. The pt was followed by laboratory personnel using both systems simultaneously. The result was to delay the removal of the arterial lines until after 6pm, an appropriate action. Had cath lab & cicu relied upon the results of the device, the arterial lines would have been requested to have been removed at least 1 1/2 hrs earlier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 28387 |
| MDR Report Key | 28387 |
| Date Received | 1995-11-06 |
| Date of Report | 1995-11-02 |
| Date of Event | 1995-08-24 |
| Date Facility Aware | 1995-11-02 |
| Report Date | 1995-11-03 |
| Date Reported to FDA | 1995-11-03 |
| Date Added to Maude | 1995-12-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR. |
| Generic Name | MICROCOAGULATION INSTRUMENT |
| Product Code | JBT |
| Date Received | 1995-11-06 |
| Lot Number | ACV027, ACV024 |
| ID Number | ACT + CARTRIDGES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 29315 |
| Manufacturer | INTERNATION TECHNIDYNE CORP. |
| Manufacturer Address | 23 NEVSKY ST EDISON NJ 08820 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1995-11-06 |