BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION SET
Received Jan 5, 2023 · Event occurred Dec 15, 2022
Report 9616066-2022-02139 · MDR key 16109541
Device
Generic name
Intravascular Administration Set
Manufacturer
Sistemas Medicos Alaris, S.a. De C.v.Model number
20350ECatalog number
20350E
Lot number
22079056
Product problems
- Obstruction of Flow
- Obstruction of Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: A COMPLAINT OF TUBING COMING BENT WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF TUBING KINKED COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 20350E, LOT NUMBER 22079056 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) IN 1 LOT NUMBER WERE BUILT ON 04JUL2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION SETS EXPERIENCED KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TPN BEEPS OCCLUDED VERY FREQUENTLY AND UPON INSPECTION IT IS EVIDENT THAT THE TUBING ON EITHER SIDE OF THE TPN FILTER IS CAVING INTO ITSELF AND PINCHING THE TUBING. THEY REPLACED THE FILTER WITH ANOTHER ONE AND THE SAME ISSUE IMMEDIATELY HAPPENED WITH THE REPLACEMENT.