FDA Adverse Event
Other
Summary report: N
CARMEDA CIRCUIT - HEPARIN COATED
MDR report key: 1000003
·
Received April 14, 2008
Report
- Report Number
- MW5005531
- Event Type
- Other
- Date Received
- April 14, 2008
- Date of Event
- January 20, 2008
- Report Date
- April 14, 2008
- Manufacturer
- MEDTRONIC
- Product Code
- DTZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THIS WAS A NEWBORN WITH A LARGE DIAPHRAGMATIC HERNIA, WHO WAS PLACED ON EXTRACORPORAL MEMBRANE OXYGENATION - ECMO-. IMMEDIATELY AFTER ECMO WAS BEGUN, SHE DEVELOPED DIFFUSE PETECHIAL LESIONS WHICH PROGRESSED TO PURPURA AND HYPERTENSION, THEN DIC. SHE CONTINUED TO DETERIORATE AND DIED FROM HEMORRHAGE SECONDARY TO DIC. HEPARIN COATED CARMEDA TUBING WAS USED DURING ECMO AND THIS REPORT IS BEING FILED RETROSPECTIVELY AFTER THE HEPARIN RECALL AND THE 04/08/08 FDA LETTER TO MANUFACTURERS ASKING THEM TO CONSIDER WITHDRAWAL OF HEPARIN COATED DEVICES. DIAGNOSIS OR REASON FOR USE: OXYGENATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARMEDA CIRCUIT - HEPARIN COATED | CARMEDA CIRCUIT - HEPARIN COATED | DTZ | MEDTRONIC | * | 8664127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DA | Other |