MICRO-VOLUME EXTENSION SET
Received Apr 30, 2021 · Event occurred Dec 11, 2020
Report 1416980-2021-02530 · MDR key 11752006
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2N3350
Lot number
ASKU
Product problems
- Crack
- Fluid/Blood Leak
- Crack
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES OR CRACKS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED, INCLUDING PRESSURE AND CLEAR PASSAGE TESTING; AND NO BLOCKAGE OR LEAKS WERE OBSERVED. FURTHERMORE, PULL TESTING WAS COMPLETED WITH NO SEPARATION DETECTED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED DUE TO A CRACK. IT WAS FURTHER REPORTED, THE ¿ARTERIAL LINE READING WAS NOT CONSISTENT WITH PRE FLUID CHANGE READINGS¿ AND ¿BLOOD WAS BACKING UP FROM THE PATIENT THROUGH THE TUBING¿. THE NURSE OBSERVED THE ¿THE MEDICATION TUBING AT THE FILTER¿ WAS CRACKED AND LEAKING. THIS LINE HAD HEPARIN AT A TKO (TO KEEP OPEN) RATE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.