FDA Adverse Event
Malfunction
Summary report: N
ECC PACK W/PEDIATRIC QUADROX ID
MDR report key: 3912104
·
Received May 13, 2014
Report
- Report Number
- 2248146-2014-00070
- Event Type
- Malfunction
- Date Received
- May 13, 2014
- Date of Event
- April 14, 2014
- Report Date
- April 14, 2014
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DWE
- PMA / PMN Number
- K080592
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED OR TOOT CAUSE IDENTIFIED. DEVICE HISTORY WAS REVIEWED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED COMPLAINT. THE FACILITY WAS ABLE TO USE THE KIT BY SWITCHING OUT STOPCOCKS WITHOUT INCIDENT. (B)(4).
Description of Event or Problem · 1
THE STOPCOCKS ON THE ECMO CIRCUIT CRACKED DURING USE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285496 | ECC PACK W/PEDIATRIC QUADROX ID | CARDIOPULMONARY DEVICE | DWE | DATASCOPE CORP. | BEQ-TOP 24105 | 16450-04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 DA |