Volumat™ Line VL ST 02-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04250273714272), received between Dec 27, 2016 and Jan 5, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  THE CUSTOMER REPORTED CHEMOTHERAPY DRUG LEAK FROM THE LUER LOCK CONNECTED TO THE IV TUBING. THERE WAS NO PATIENT INJURY REPORTED PER THE CUSTOMER. THE CUSTOMER ALSO INDICATED THAT THE SAMPLE AND THE LOT NUMBER ARE NOT AVAILABLE FOR FURTHER EVALUATION. SINCE A SAMPLE IS NOT AVAILABLE FOR EVALUATION A COMPLETE ANALYSIS COULD NOT BE PERFORMED. SINCE THE BATCH NUMBER IS MISSING WE WERE NOT ABLE TO CHECK ANY RETAINED SAMPLES OR PRODUCTION DOCUMENTS. THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6226317 ↗
• MalfunctionJan 4, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK FROM THE GREEN CONNECTOR OF THE AGILIA INFUSION SET. PER THE CUSTOMER NO PATIENT ISSUES WERE REPORTED FOR THIS EVENT. A SAMPLE WILL NOT BE RETURNED AND A BATCH NUMBER IS NOT AVAILABLE FOR EVALUATION. THE CUSTOMER PROVIDED A PICTURE OF THE INCIDENT FOR FURTHER EVALUATION. SINCE A SAMPLE IS NOT AVAILABLE FOR EVALUATION A COMPLETE ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS MISSING WE WERE NOT ABLE TO CHECK ANY RETAIN SAMPLES OR PRODUCTION DOCUMENTS. THE RECEIVED PICTURE IS NOT SHARP ENOUGH AND WE WERE NOT ABLE TO CONFIRM THE LEAKAGE AND ITS ORIGIN. THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Information

  MAUDE report 6223858 ↗
• MalfunctionDec 27, 2016Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  ON DEC 15,2015 AN FRESENIUS (B)(4) EMPLOYEE CALLED IN A REPORT FROM (B)(6). THE CUSTOMER REPORTED A CHEMO LEAK DURING USE OCCURRING DISTAL TO THE SAFETY CLAMP. NO PATIENT INJURY OR ADVERSE REACTION WAS REPORTED. THE CUSTOMER STATED NO SAMPLE IS AVAILABLE TO BE RETURNED FOR EVALUATION, BUT PICTURES ARE AVAILABLE. AN UPDATE FROM THE FRESENIUS-(B)(4) REPRESENTATIVE TO CORRECT HER STATEMENT, LEAK OCCURRED PROXIMAL TO THE SAFE CLIP, WHERE THE SAFE CLIP MEETS THE PUMPING SEGMENT. SHE ALSO STATED THAT PICTURES WERE AVAILABLE. INVESTIGATION: WE DID NOT RECEIVE A SAMPLE BUT A PHOTO FOR INVESTIGATION. BASED ON THE PICTURE WE FOUND A DROP OF LIQUID UNDER THE SILICON TUBE HOWEVER USING THE PICTURE WE UNFORTUNATELY COULD NOT DETERMINE THE EXACT COMPLAINT REASON OR THE ROOT CAUSE. WE PERFORMED A FREE FLOW AND TIGHTNESS TEST ON ONE RETAIN SAMPLE OF THE COMPLAINED BATCH WITHOUT FINDING ANY NON-CONFORMITY. THE INVESTIGATION OF THE PRODUCTION DOCUMENTS DID NOT SHOW ANY DEVIATIONS RELATED TO THE COMPLAINT REASON. WITHOUT AN AFFECTED SAMPLE A MORE DETAILED ANALYSIS IS UNFORTUNATELY NOT POSSIBLE. THE ROOT CAUSE FOR THIS COMPLAINT REASON IS NOT KNOWN AS WE DID NOT RECEIVE THE SAMPLE. AS WE RECEIVED SIMI

  Patient problems: No Information

  MAUDE report 6206709 ↗

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