Infusomat® 363902Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046964294730), received between Jul 18, 2023 and Feb 8, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: REPEATED PUMP ALARMS- AIR DETAILED INQUIRY DESCRIPTION: MED CENTER HEALTH IS EXPERIENCING FREQUENT PUMP ALARMS. THIS MOST RECENT REPORT IS FOR AIR IN LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18673526 ↗
• MalfunctionFeb 8, 2024Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: REPEATED AIR IN LINE ALARMS. DETAILED INQUIRY DESCRIPTION: MED CENTER HEALTH WENT LIVE WITH SPACE PUMPS IN MID DECEMBER. THE HAVE EXPERIENCED INTERMITTENT ISSUES WITH AIR IN LINE AND WHEN IT OCCURS THEY ARE REPEATING AND UNMANAGEABLE. THEY HAVE BEEN RECEIVING ALMOST ALL UPDATED TUBING SINCE GO-LIVE. THE FOLLOWING STATEMENT IS DIRECTLY FROM THE CUSTOMER. WE HAVE STILL HAD ISSUES WITH AIR IN LINE ASSOCIATED WITH THE PORTLESS TUBING. IT IS NOT MAKING A NOTABLE DIFFERENCE IN THE RECOVERY UNIT THE PATIENTS THAT COME TO US WITH PORTLESS TUBING VS THE ONES THAT COME TO US WITH ORIGINAL PORT TUBING. TODAY FOR EXAMPLE, OUT OF OUR 7 PUMPS PATIENT CAME UP ON 3 HAVE HAD CONTINUOUS ISSUES WITH THE MOST NOTABLE TO BE THE NOREPINEPHRINE INFUSION. ESSENTIALLY WE HAVE BEEN GOING NO MORE THAN 5 MINUTES WITHOUT ALARMS WHILE RECOVERING THIS HEART. IT IS UNCLEAR IF THIS CUSTOMER IS EXPERIENCING ACTUAL AIR IN THE LINE OR NOT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672352 ↗
• MalfunctionJan 9, 2024Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: FREQUENT AIR IN LINE ALARMS. DETAILED INQUIRY DESCRIPTION: CUSTOMER STATES THAT AIR IN LINE ALARMS ARE OCCURRING REGULARLY. CUSTOMER STATES THAT THEY ARE PRIMING ON THE PUMP AND CAREFULLY DE-AIRING THE LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476600 ↗
• MalfunctionOct 24, 2023Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIR IN LINE ALARMS WITH NO AIR BUBBLES PRESENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998764 ↗
• MalfunctionJul 18, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: THE CLINICIAN WAS STRUGGLING WITH AIR IN LINE DURING VANCOMYCIN INFUSION NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343372 ↗
• MalfunctionJul 18, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: THE CLINICIAN WAS STRUGGLING WITH AIR IN LINE DURING VANCOMYCIN INFUSION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343371 ↗
• MalfunctionJul 18, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: THE CLINICIAN WAS STRUGGLING WITH AIR IN LINE DURING VANCOMYCIN INFUSION NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343339 ↗
• MalfunctionJul 18, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: THE CLINICIAN WAS STRUGGLING WITH AIR IN LINE DURING VANCOMYCIN INFUSION NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343338 ↗