MEDEX EXTENSION FILTER SETS
Received May 4, 2023 · Event occurred Mar 31, 2023
Report 3012307300-2023-05058 · MDR key 16868974
Device
Generic name
Filter, Infusion Line
Manufacturer
Smiths Medical Asd, Inc.Model number
MX448HFBCatalog number
MX448HFB
Lot number
4355305
Product problems
- Obstruction of Flow
- Obstruction of Flow
Patient
10 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OTHER TEXT: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING INFUSION THE IV PUMP WAS ALARMING OCCLUSION. CLAMPS WERE OPEN, LINE PATENT, AND NO KINKS. UPON DISCONNECTING THE LINE THERE WAS "NO FLOW". THE CUSTOMER CHANGED THE FILTER, AND THE LINE BEGAN TO FLOW FREELY. THE CUSTOMER NOTED THAT THE REPORTED DEVICE WAS A SUBSTITUTE PRODUCT, AND IT WAS "SLIGHTLY SMALLER" THAN THEIR USUAL FILTER AND HAVE SINCE SWITCHED BACK TO THEIR ORIGINAL FILTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED THEREFORE DEVICE ANALYSIS COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THERE WERE NO DISCREPANCIES OBSERVED DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION.