CUSTOM TUBING PACK
Report
- Report Number
- 2248146-2017-00008
- Event Type
- Malfunction
- Date Received
- February 1, 2017
- Date of Event
- January 6, 2017
- Report Date
- February 26, 2020
- Manufacturer
- DATASCOPE FAIRFIELD
- Product Code
- DWE
- PMA / PMN Number
- K080592
- Removal / Correction Number
- 2248146-02/16/2017-001C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. COMPLAINT RECORD # (B)(4).
A VISUAL REVIEW OF PRODUCTS IN STOCK FROM THIS LOT HAS CONFIRMED THE REPORTED EVENT OF THE KITS BEING BUILT INCORRECTLY. REFERENCE: FIELD CORRECTION 2248146-02/16/2017-001C. (B)(4).
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WE'RE UNABLE TO COMPLETE AN EVALUATION ON THE AFFECTED PRODUCT. WHEN IT'S PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH ADDITIONAL FINDINGS. WE WILL CONTINUE IN OUR EFFORTS TO FOLLOW UP WITH THE CUSTOMER FOR IT'S RETURN. (B)(4).
IT WAS REPORTED THAT PRIOR TO USE THE CUSTOMER OBSERVED THAT THE CARDIOPULMONARY TUBING PACK OXYGENATOR HAD INCORRECT CAPS ON THE HYDRO PHOBIC MEMBRANE FILTER.
IT WAS REPORTED THAT PRIOR TO USE THE CUSTOMER OBSERVED THAT THE CARDIOPULMONARY TUBING PACK OXYGENATOR HAD INCORRECT CAPS ON THE HYDRO PHOBIC MEMBRANE FILTER.
IT WAS REPORTED THAT PRIOR TO USE THE CUSTOMER OBSERVED THAT THE CARDIOPULMONARY TUBING PACK OXYGENATOR HAD INCORRECT CAPS ON THE HYDRO PHOBIC MEMBRANE FILTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75496 | CUSTOM TUBING PACK | TUBING, PUMP, CARDIOPULMONARY BYPASS | DWE | DATASCOPE FAIRFIELD | 3000033848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |