MalfunctionJOD
PALL CARDIOPLEGIA PLUS FILTER W/SOLUTION SPIKE
Received May 3, 2007 · Event occurred Apr 4, 2007
Report 2647898-2007-00008 · MDR key 959850
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Product code (JOD)
Model (CPS02NS)
Device
Generic name
Jod: Cardiopulmonary Bypass Cardiotomy Suction Line Blood Fi
Manufacturer
Pall Biomedical, Inc.Model number
CPS02NSCatalog number
NA
Lot number
632002
Product problems
- Particulates
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATION BEGUN, BUT NOT YET COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN INSPECTION OF THE DEVICES, PRIOR TO SHIPMENT TO ANOTHER MANUFACTURER, FREE PARTICULATE MATTER WAS DISCOVERED IN THE DOWNSTREAM SIDE.