FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON JR. SIGNATURE PLUS SYSTEM
MDR report key: 1864819
·
Received September 28, 2010
Report
- Report Number
- 2248721-2010-00139
- Event Type
- Malfunction
- Date Received
- September 28, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 28, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JPA
- PMA / PMN Number
- K020798
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MANUFACTURER AWAITING ADDITIONAL INFORMATION FOR FURTHER COMPLAINT EVALUATION.
Description of Event or Problem · 1
HEALTHCARE PROVIDER REPORTS: ACT RESULTS LOWER THAN REFERENCE/EXPECTED. ON 09/15/2010, PATIENT WAS TESTED ON 2 INSTRUMENTS, ONE GENERATED A 160 AND THE OTHER GENERATED 154. SHEATH WAS PULLED AT 160 WHICH WAS THE TARGET. HOWEVER, THE PATIENT APPEARED TO HAVE SIGNIFICANT ANTICOAGULATION, BLED DURING THE PULL AND SHOWED EVIDENCE OF BLEEDING IN THE ORAL MUCOSA. A SAMPLE WAS SENT TO THE LAB FOR PTT TESTING AND THE RESULT WAS >130. THE CUSTOMER REPORTS CHECKING TO KNOW WHETHER THE HEPARIN GIVEN WAS A NEWER LOT. THE MEDICAL DIRECTOR HAS PAUSED THE INTERVENTIONAL PROGRAM UNTIL INVESTIGATION OF THE ISSUE IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON JR. SIGNATURE PLUS SYSTEM | HEMOCHRON JR. SIGNATURE PLUS INST | JPA | INTERNATIONAL TECHNIDYNE CORP. | PSIG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |