MICRO-VOLUME EXTENSION SET
Received Jul 10, 2023 · Event occurred Jun 2, 2023
Report 1416980-2023-03454 · MDR key 17293117
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
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE FILTER OF A NON-DEHP MICRO-VOLUME EXTENSION SET WAS CRACKED AND LEAKED. THIS WAS IDENTIFIED DURING PATIENT INFUSION WITH LORAZEPAM USING A NON-BAXTER INFUSION PUMP. THE LEAK WAS EITHER FROM THE BONDED JOINT WHERE THE TUBING ENTERS THE FILTER OR FROM THE AIR VENT OF THE FILTER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.