MEDEX LOGICAL PRESSURE MONITORING SYSTEM
Received Sep 16, 2022
Report 3012307300-2022-19539 · MDR key 15442500
Device
Generic name
Catheter, Pressure Monitoring, Cardiac
Manufacturer
Smiths Medical International, Ltd.Catalog number
MX9624RCZ
Lot number
4232643
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO DEVICE WAS RETURNED FOR INVESTIGATION. A PHOTO OF THE DEVICE WAS SENT IN. FROM THAT PHOTO IT WAS SEEN THAT THE DEVICE WAS BROKEN BETWEEN LOCAL DOME AND RED TRIGGER FLUSH. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED NO OBSERVATIONS RECORDED DURING THE MANUFACTURING PROCESS TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THE LOT NUMBER. THIS ISSUE WAS FIRST IDENTIFIED IN AUGUST 2018. ROOT CAUSED WAS FOUND AND CONFIRMED IN PACKAGING PROCESS. AS A CORRECTION THE RELATED PROCEDURE WAS UPDATED AND TRAINED IN 31-AUG-2020. SINCE THEN THERE WAS NO OCCURRENCES IDENTIFIED OR CUSTOMER COMPLAINT ABOUT THIS ISSUE RECEIVED. THIS IS CONSIDERED TO BE ISOLATED INCIDENT ONLY. IF IND/PREANDA, GIVE PROTOCOL # - UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A FAULTY ARTERIAL LINE WHICH BROKE IN TWO PLACES WHILE CONNECTED TO A PATIENT. NO FORCE WAS APPLIED TO THE DEVICE TO CAUSE THIS AND THE DEVICE HAD TO BE CHANGED MID CASE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.