INTRAVASCULAR EXTENSION SETS AND ACCESSORIES
Received Jun 10, 2021 · Event occurred Apr 26, 2021
Report 1416980-2021-03533 · MDR key 11976110
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2N3382
Lot number
NI
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION FOR H10: BASED ON FURTHER INVESTIGATION, THE MOST PROBABLE CAUSE WAS DETERMINED TO BE RELATED TO THE END USER/METHODS EXCEEDING THE PRODUCT PRESSURE SPECIFICATIONS OF 45PSI. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED A MICRO-VOLUME EXTENSION SET LEAKED. DURING PRIMING THE LEAK WAS OBSERVED ORIGINATING FROM THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.