Infusomat® 363230Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046964294495), received between Jun 6, 2019 and Nov 24, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

3 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0640-2026 · Root cause: Process control · FDA record ↗

2. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2403-2024 · Root cause: Process control · FDA record ↗

3. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: "A NURSE ENTERED THE ROOM AND NOTICED CHEMO WAS STARTING TO DRIP FROM THE WHITE PORT, UNDER WHERE THE SECONDARY LINE ATTACHES. DAUNORUBACIN WAS INFUSING. APPROXIMATELY 1ML OR LESS HAD LEAKED. CHUX WAS IMMEDIATELY PLACED UNDER AREA, AND RED FLUID WAS OBSERVED ON THE CHUX. CHEMO WAS COMPLETED, AND TUBING WAS REMOVED FROM ROOM PER PROTOCOL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891868 ↗
• MalfunctionOct 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: NURSE RESPONDED TO CALL FROM PATIENT IN HIS ROOM. WHEN SHE ENTERED THE ROOM SHE FOUND APPROXIMATELY 50ML OF CHEMOTHERAPY CISPLATIN ON THE FLOOR. THE IV LINE BECOME DISCONNECTED AT PICC LINE AND TUBING. THE REPORT ALSO STATED THAT THIS MAY HAVE BEEN A CASE OF THE NURSE NOT TIGHTENING THE CONNECTIONS OF ALL PIECES (TUBING, ANTI-SYPHON VALVE, EQUASHIELD LL-Y) ALL TOGETHER. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9220485 ↗
• MalfunctionSep 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: END USER REPORTS THAT, "WHEN HANGING PEMETREXED THE LINE UNRAVELED AND CAME UNDONE AND LEAKED ONTO PUMP, TABLE AND FLOOR." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075092 ↗
• MalfunctionJul 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PRODUCT UNTWISTED AND DISCONNECTED DURING CHEMOTHERAPY. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8793620 ↗
• MalfunctionJul 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PRODUCT IS UNTWISTING AFTER CONNECTION AND CHEMO LEAKED. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8793619 ↗
• MalfunctionJun 6, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: THE MALE EQUASHIELD CONNECTOR RELEASED FROM THE ULTRASITE VALVE. THE CLINICIAN PROGRAMMED THE PUMP AND UNCLAMPED THE CHEMOTHERAPY LINE PRIOR TO ADMINISTRATION. WHEN EQUASHIELD CONNECTOR WAS APPLIED AND CLICKED IN PLACE, THE ENTIRE APPLIANCE (STILL CONNECTED) POPPED OFF THE BBRAUN CLAVE. SALINE FROM CHEMO BAG LEAKED OUT ONTO CHUX AND LESS THAN 5 ML OF THE CHEMO LEAKED ONTO CHUX BEFORE LINE WAS CLAMPED. THE NURSE HAD A MINIMAL CHEMO SPILL (MINIMAL DUE TO SALINE PRIMED CHEMO LINE). NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8674569 ↗
• MalfunctionJun 6, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: THE MALE EQUASHIELD CONNECTOR RELEASED FROM THE ULTRASITE VALVE, CAUSING CHEMO LEAKAGE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8674567 ↗