inforMED
MalfunctionDXO

VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM

Received Dec 30, 2025

Report 2015691-2025-10624 · MDR key 23923290

Device

Generic name

Catheter, Continuous Flush

Model number

PXVMP184

Lot number

66691943

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ADDED INFORMATION TO SECTION H6 (TYPE OF INVESTIGATION), CODE 4112 - ANALYSIS OF INFORMATION PROVIDED BY USER/THIRD PARTY WAS SELECTED SINCE THE CODE "ANALYSIS OF IMAGES" IS NOT AVAILABLE. UPDATED SECTION H6 (COMPONENT CODE), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). FINALLY, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION DESPITE DUE DILIGENT ATTEMPTS. WITHOUT RETURN OF THE PRODUCT, A COMPLETE INVESTIGATION OF THE REPORTED EVENT IS UNABLE TO BE PERFORMED. NEVERTHELESS, IMAGES WERE PROVIDED FOR REVIEW. BASED ON THE IMAGE EVALUATION, THE REPORT OF "VAMP TUBING DETACHED" WAS CONFIRMED. FIRST IMAGE SHOWED A TYVEK POUCH FROM REPORTED MODEL AND LOT NUMBER AND OTHER TWO IMAGES SHOWED WHAT APPEARED TO BE PRESSURE TUBING DETACHED FROM VAMP RESERVOIR BOND JOINT. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT INVOLVED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. IT COULD BE DETERMINED THAT THE ISSUE IS RELATED TO THE BONDING PROCESS DURING THE DEVICE MANUFACTURING. CORRECTIVE ACTIONS ARE BEING IMPLEMENTED IN ORDER TO ELIMINATE THE CAUSE OF THE NON-CONFORMITY AND PREVENT RECURRENCE OF THIS TYPE OF COMPLAINT. THERE ARE MANUFACTURING CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO THE REPORTED MALFUNCTION.

Additional Manufacturer Narrative

THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

Description of Event or Problem

AS REPORTED, DURING BLOOD SAMPLING WITH THIS PRESSURE MONITORING SET, THE VAMP TUBING DETACHED. THE TUBING COULD NOT BE REASSEMBLED AS IT WAS COMPLETELY DETACHED. IT WAS NOTED THAT THIS ISSUE HAS OCCURRED PREVIOUSLY. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.