Volumat™ Line VL ST 10-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04250273714517), received between Jan 4, 2017 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); 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 THAT THE TRANSFUSION SET SPIKE FELL OUT OF THE IV BAG CAUSING A LEAK. THE EVENT DID NOT OCCUR DURING INFUSION AND THE IV BAG WAS JUST HANGING UP ON THE POLE. THE CUSTOMER HAD TO USE A CHEMO SPILL KIT TO CLEAN THE SPILL. THE DRUG AVASTIN GOT ON THE NURSE BUT WAS NOT HARMED. THE DRUG SPILL DID NOT GET ON THE PATIENT. THE CUSTOMER DID NOT PROVIDE ANY SAMPLE, PICTURES OR INFORMATION REGARDING THE BATCH NUMBER. THEREFORE, A DETAILED ANALYSIS COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Information

  MAUDE report 6226866 ↗
• MalfunctionJan 5, 2017Fluid/Blood Leak; Leak/Splash; Chemical Spillage; Fluid/Blood Leak; Leak/Splash; Chemical Spillage

  THE CUSTOMER REPORTED THE SET WAS BROKEN BELOW THE DRIP CHAMBER. THE INFUSION TREATMENT HAD NOT BEEN STARTED AS THE CUSTOMER WAS PUTTING THE TREATMENT ON THE POLE. THE DRUG CAME INTO CONTACT WITH THE NURSE, BUT SHE WAS NOT HARMED. THE DRUG DID NOT SPILL ON THE PATIENT. THE LEAK WAS CLEANED UP USING A CHEMO SPILL KIT. THERE WAS NO SAMPLE RETURNED, BUT PICTURES WERE AVAILABLE FOR REVIEW. THE BATCH NUMBER IS UNKNOWN. THE INSPECTION OF THE PROVIDED PHOTOGRAPHS SHOWED A VISIBLE HOLE IN THE SILICONE TUBE (IT IS A PART OF THE PUMP SEGMENT) NEXT TO THE TRANSPARENT ADAPTER. THE PVC TUBES AND DRIP CHAMBER WERE FOUND TO BE SEPARATED. A VISIBLE MARK OF THE DRIP CHAMBER CONNECTOR (THIS IS THE POINT WHERE THE TUBING IS PUSHED) WAS ALSO PRESENT. WITHOUT THE BATCH NUMBER, THE PRODUCTION DOCUMENTS COULD NOT BE INVESTIGATED AND NO RETAIN SAMPLES COULD BE TESTED. THE CAUSE OF THE LEAK WAS LIKELY DUE TO INSUFFICIENT GLUE APPLIED ON THE TUBE DURING THE MANUFACTURING PROCESS. A CAPA WAS INITIATED IN THE PRODUCTION FACILITY TO ADDRESS THIS MANUFACTURING ISSUE.

  Patient problems: Chemical Exposure; No Known Impact Or Consequence To Patient

  MAUDE report 6226596 ↗
• MalfunctionJan 4, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SET WAS LEAKING DUE TO THE SPIKE DISCONNECTING FROM THE BAG DURING SETUP WHILE AT PATIENT BEDSIDE. THE SET WAS LEAKING THE DRUG GEMZAR AND THE NURSE AND PATIENT WERE EXPOSED BY DIRECT CONTACT TO THE DRUG. THE NURSE TAPED THE IV BAG TO THE SET WITH PHARMACY TAPE AND IT IS STILL NOT HOLDING THEM TOGETHER. DUE TO THE EXPOSURE TO THE DRUG THE NURSE AND PATIENT HAD TO WASH UP WITH SOAP AND CHANGE THEIR CLOTHES. AN INVESTIGATION COULD NOT BE PERFORMED SINCE THERE WAS NO SAMPLE, NO PICTURES AND NO BATCH NUMBER AVAILABLE. THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: Chemical Exposure

  MAUDE report 6223852 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121613. 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