FDA Adverse Event
Death
Summary report: N
HEMOCHRON MICROCOAGULATION SYSTEM
MDR report key: 1205877
·
Received October 20, 2008
Report
- Report Number
- 2248721-2008-00018
- Event Type
- Death
- Date Received
- October 20, 2008
- Date of Event
- September 24, 2008
- Report Date
- October 20, 2008
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JBP
- PMA / PMN Number
- K960749
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER EVALUATION / INVESTIGATION CURRENTLY IN PROCESS.
Description of Event or Problem · 1
DEVICE 1 OF 2 - CUSTOMER REPORTS 4 CRITICALLY ILL PEDIATRIC ECMO PATIENTS EXPIRED OVER AN UNSPECIFIED SIX WEEK PERIOD. DURING TREATMENT, CLOTTING TIME WAS MEASURED USING HEMOCHRON ACT-LR / SIGNATURE ELITE INSTRUMENTS. AS 2 SIGNATURE ELITE INSTRUMENTS ARE IN USE, CUSTOMER IS UNABLE TO IDENTIFY WHICH INSTRUMENT USED WITH SPECIFIC PATIENTS. CUSTOMER REVIEWING MEDICATION REGIMEN FOR CAUSALITY. THIS REPORT IS FOR DEVICE 1 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON MICROCOAGULATION SYSTEM | ACT-LR ASSAY / SIGNATURE ELITE INSTRUMENT | JBP | INTERNATIONAL TECHNIDYNE CORP. | SIGNATURE ELITE | ACT-LR-UNAVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Death |