FDA Adverse Event
Malfunction
Summary report: N
01970110#QUADROX-I WITHOUT FILTER
MDR report key: 3831963
·
Received March 7, 2014
Report
- Report Number
- 8010762-2014-00123
- Event Type
- Malfunction
- Date Received
- March 7, 2014
- Date of Event
- February 14, 2014
- Report Date
- February 24, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY
- Product Code
- DWC
- PMA / PMN Number
- K090511
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE MFR HAS RECEIVED THE DEVICES FOR INVESTIGATION. THE DEVICES ARE UNDER GOING LABORATORY INVESTIGATION TO DETERMINE THE ROOT-CAUSE. A SUPPLEMENTAL MEDWATCH WILL FOLLOW ONCE NEW INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS LEAKAGE ON CONNECTOR WHILE PRIMING. AS THEY CONNECT A STOPCOCK, THEY HAVE A LEAKAGE ON LL. IF THEY TURN ON THE PUMP LEAKAGE INCREASED. REF #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139482 | 01970110#QUADROX-I WITHOUT FILTER | MICROPOROUS MEMBRANE OXYGENATOR | DWC | MAQUET CARDIOPULMONARY | 70103.1733 | 70093582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |