FDA Adverse Event
Malfunction
Summary report: N
QUADROX-ID PEDIATRIC
MDR report key: 3123697
·
Received May 3, 2013
Report
- Report Number
- 8010762-2013-00026
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Report Date
- April 4, 2013
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTZ
- PMA / PMN Number
- K100278
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MAQUET MEDICAL SYSTEMS (B)(4) SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4), MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Description of Event or Problem · 1
THE HOSPITAL REPORTED MULTIPLE INSTANCES OF CLOTTING, REQUIRING DEVICE OR CIRCUIT CHANGE. CLOT FORMATION WAS REPORTED TO HAVE OCCURRED ON THE VENOUS SIDE OF THE MEMBRANE TO THE POINT THAT BLOOD CEASED IN THE CIRCUITS. NO INFO IS AVAILABLE TO DETERMINE DURATION OF USE WHEN CLOTTING WAS OBSERVED. NO DEVICE, EVENT, OR PATIENT SPECIFICS HAVE BEEN PROVIDED AT THIS TIME. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195710 | QUADROX-ID PEDIATRIC | OXYGENATOR | DTZ | MAQUET CARDIOPULMONARY AG | BE-HMOD30000 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |