FDA Adverse Event
Malfunction
Summary report: N
CUSTOM PACK - NEO
MDR report key: 3980182
·
Received June 5, 2014
Report
- Report Number
- 2248146-2014-00088
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- May 9, 2014
- Report Date
- May 9, 2014
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DWE
- PMA / PMN Number
- K080592
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO TESTING CAN BE PERFORMED TO CONFIRM THE COMPLAINT. HOWEVER, AN INVESTIGATION INTO THIS ISSUE IS BEING CONDUCTED TO DETERMINE THE ROOT CAUSE OF THE EVENT. WHEN THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS. INTERNAL COMPLAINT # (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON OPENING THE KIT, THE "BRIDGE" LINE WAS TWISTED AND TORQUED. ALSO, LUER PORTS AND PIGTAILS WERE NOT CONNECTED AND FOUND LOOSE IN THE BOTTOM OF THE KIT. NO PATIENT WAS INVOLVED. RELATED TO MFR REPORT# 2248146-2014-00089.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330415 | CUSTOM PACK - NEO | CARDIOPULMONARY DEVICE | DWE | DATASCOPE CORP. | BEQ-TOP 31203 | 16351-05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |