FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 155598
·
Received March 9, 1998
Report
- Report Number
- 1317749-1998-00002
- Event Type
- Malfunction
- Date Received
- March 9, 1998
- Manufacturer
- *
- Product Code
- DQO
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF INVESTIGATION: THE DEVICE IN QUESTION WAS NOT RETURNED. THIS DEVICE WAS MFG IN 11/1994 AND THE PRODUCTION RECORDS HAVE BEEN ARCHIVED. HOWEVER, CO HAS NO PRIOR COMPLAINTS INVOLVING CLOTTING OF BLOOD ON THE END OF THE CATHETER AND NO SIMILAR COMPLAINTS. THE INSTRUCTIONS FOR USE WARN THAT "ADEQUATE HEPARINIZATION" (PROCESS OF ADMINISTERING HEPARIN, A KNOWN ANTICOAGULANT) "MUST BE MAINTAINED DURING ECMO" AND PRIOR TO CANNULATION, "IT IS IMPORTANT THAT HEPARIN HAS BEEN GIVEN, AND ENOUGH TIME ALLOWED FOR RECIRCULATION." COMMENTS AND CORRECTIVE ACTIONS: BASED ON THE INFO AVAILABLE, THERE IS NO EVIDENCE TO SUPPORT THAT A MFG ERROR HAS OCCURRED AND IT CAN ONLY BE SPECULATED THAT ADEQUATE HEPARINIZATION WAS NOT ACHIEVED BY THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | DQO | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |