Volumat™ Line VL ON 72-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250273714395), received between Jan 5, 2017 and Jan 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K121613, K220301); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THEY PRIMED THE TUBING WITH SALINE FIRST AND IT WAS DURING SETUP OF PUTTING THE TUBING IN THE PUMP THAT THEY NOTICED THAT IT WAS LEAKING. THEY SAID WHAT WAS COMING OUT WAS MOST LIKELY SALINE BUT THEY WERE HANGING PACLITAXEL SO SOME OF THE DRUG COULD HAVE DRIPPED OUT BUT NOT SURE. THE SPILL WENT ONTO THE FLOOR AND WAS TREATED AS A CHEMO SPILL. THE CUSTOMER STATED NONE OF THE SPILLED LIQUID GOT ON THE PATIENT OR THE NURSE. THE SET WAS LEAKING NEXT TO THE SMART CLIP RIGHT AT THE PUMPING SEGMENT. A SAMPLE INVESTIGATION COULD NOT BE PERFORMED AS WE DID NOT RECEIVE THE ACTUAL COMPLAINT SAMPLE. WE RECEIVED VIDEO WHICH SHOWED LEAKAGE AT BLUE SAFETY CLAMP. HOWEVER, BASED ON THE VIDEO, WE CANNOT DETERMINE WHAT WAS THE CAUSE OF THE LEAK. WITHOUT AN ACTUAL SAMPLE A DETAILED ANALYSIS IS UNFORTUNATELY NOT POSSIBLE. WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE RETAIN SAMPLE OF THE COMPLAINT BATCH AND COULD NOT FIND ANY NON-CONFORMITY. THE REVIEW OF OUR PRODUCTION DOCUMENTS DID NOT SHOW ANY DEVIATIONS RELATED TO THE COMPLAINT REASON. BASED ON THE INVESTIGATION RESULTS, A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6226308 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121613, K220301. One submission often covers many models, so check the product and lot details in each record.

• Z-2064-2019 · Jun 24, 2019 · Terminated
  VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to
• Z-0362-2019 · Dec 2, 2017 · Terminated
  Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to