Infusomat® 363032Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964294297), received between Jun 29, 2017 and Jun 26, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Nov 1, 2023Open, Classified

   In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.

   Z-0355-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS A WHITE PIECE OF PLASTIC WITHIN THE TUBING WAS OBSTRUCTING THE FLUID PATH OF THE TUBING. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10199472 ↗
• MalfunctionJun 26, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS A WHITE PIECE OF PLASTIC WITHIN THE TUBING WAS OBSTRUCTING THE FLUID PATH OF THE TUBING. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10199471 ↗
• MalfunctionJan 29, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT EVEN THOUGH THE TUBING WAS CLAMPED, IVF KEPT DRIPPING. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9645291 ↗
• MalfunctionJan 10, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT EVEN THOUGH THE IV SET WAS CLAMPED, IVF KEPT DRIPPING INTO THE BURETROL. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9574245 ↗
• MalfunctionJan 9, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN BURETROL WHILE PRIMING SET-UP FOR LIPIDS. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9569567 ↗
• MalfunctionOct 10, 2019Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): END USER PUT VANCOMYCIN IV INTO BURETROL, DILUTED TO 50CC, THEN CLAMPED TO NS BAG. WHEN END USER RETURNED TO FLUSH THE PRODUCT, BURETROL WAS FOUND FILLED TO 150CC WITH CLAMP CLOSED. THE END USER CLOSED THE CLAMP TIGHTER BUT BURETROL REMAINED FILLED. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9176305 ↗
• MalfunctionOct 2, 2019Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT ALTHOUGH THE ROLLER CLAMP WAS PLACED IN A CLOSED POSITION, FLUID CONTINUED TO FLOW. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9145712 ↗
• MalfunctionAug 6, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: THAT FOREIGN MATTER WAS SEEN IN THE FLUID PATH. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8863811 ↗
• MalfunctionMay 28, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: "THERE IS SOME FORM OF SUBSTANCE ON THE SPIKE." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8646207 ↗
• MalfunctionApr 24, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  AS REPORTED BY THE USER FACILITY: TUBING WAS FOUND TO BE LEAKING DURING PRIMING. THE SOURCE OF THE LEAKING WAS UNABLE TO BE DETERMINED. THE LEAKAGE OCCURRED DURING THE PRIMING OF A HAZARDOUS MEDICATION. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8546997 ↗
• MalfunctionJun 29, 2017Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: AS PER REPORT," SOLUTION OF NS STILL DRIPPING INTO DRIP CHAMBER DESPITE THE FACT THAT ROLLER CLAMP ABOVE DRIP CHAMBER WAS FULLY CLOSED. INSTEAD OF EMPTYING, DRIP CHAMBER GET FILLED WITH NS SOLUTION FROM BAG ATTACHED ABOVE." NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6677738 ↗