Infusomat® 490101Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046964186103), received between Nov 16, 2018 and Apr 29, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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-2398-2024 · 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: A PIECE OF PLASTIC WAS OBSERVED IN THE LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031651 ↗
• MalfunctionMay 20, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY USER FACILITY: BRIEF INQUIRY DESCRIPTION AIR IN LINE FROM Y-CONNECTOR AT PROXIMAL PORT TO PATIENT DETAILED INQUIRY DESCRIPTION AIR IN LINE FROM Y-CONNECTOR AT PROXIMAL PORT TO PATIENT DESCRIPTION OF THE PATIENT EVENT PUMP INFUSING, NURSE NOTICED AIR IN LINE AND BUBBLING AT Y-CONNECTOR NO INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355625 ↗
• MalfunctionSep 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 3: DESCRIPTION OF THE PATIENT EVENT - PER NURSING: BURETROLS APPEAR TO HAVE SOMETHING IN THE TUBING THAT PRECIPITATES W/NS CREATING A HARD PLUG. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414358 ↗
• MalfunctionSep 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: DESCRIPTION OF THE PATIENT EVENT - PER NURSING: BURETROLS APPEAR TO HAVE SOMETHING IN THE TUBING THAT PRECIPITATES W/NS CREATING A HARD PLUG. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414354 ↗
• MalfunctionSep 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 4: DESCRIPTION OF THE PATIENT EVENT - PER NURSING: BURETROLS APPEAR TO HAVE SOMETHING IN THE TUBING THAT PRECIPITATES W/NS CREATING A HARD PLUG. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414353 ↗
• MalfunctionSep 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: DESCRIPTION OF THE PATIENT EVENT - PER NURSING: BURETROLS APPEAR TO HAVE SOMETHING IN THE TUBING THAT PRECIPITATES W/NS CREATING A HARD PLUG. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414352 ↗
• MalfunctionJun 13, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 3 : FIVE (5) PATIENTS HAVE HAD IV LINES RUPTURES. ASSESSMENT: NICU PATIENTS REQUIRING A LARGE VOLUME CONTINUOUS INFUSION (IVF, TPN ETC.), A SPACE PUMP BURETTE SET IS USED FOR THE IV ASSEMBLY. NICU STAFF HAVE OBSERVED AND RECOGNIZED FREQUENT PUMP ALARMS INDICATING AIR IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674344 ↗
• MalfunctionJun 13, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 5 : FIVE (5) PATIENTS HAVE HAD IV LINES RUPTURES. ASSESSMENT: NICU PATIENTS REQUIRING A LARGE VOLUME CONTINUOUS INFUSION (IVF, TPN ETC.), A SPACE PUMP BURETTE SET IS USED FOR THE IV ASSEMBLY. NICU STAFF HAVE OBSERVED AND RECOGNIZED FREQUENT PUMP ALARMS INDICATING AIR IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674343 ↗
• InjuryJun 13, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1 : FIVE (5) PATIENTS HAVE HAD IV LINES RUPTURES. ASSESSMENT: NICU PATIENTS REQUIRING A LARGE VOLUME CONTINUOUS INFUSION (IVF, TPN ETC.), A SPACE PUMP BURETTE SET IS USED FOR THE IV ASSEMBLY. NICU STAFF HAVE OBSERVED AND RECOGNIZED FREQUENT PUMP ALARMS INDICATING AIR IN THE TUBING. ADDITIONAL INFORMATION ONE NICU PATIENT WITH A SPACE PUMP BURETTE SET WAS RECENTLY FOUND WITH A POSITIVE BC - S. AUREUS ON (B)(6) 2022. THE PATIENT HAD A PICC LINE IN PLACE FROM (B)(6), CST DETERMINED THE CASE TO BE A SECONDARY BSI DUE TO PNEUMONIA. PATIENT BORN ON (B)(6) 2022 WITH RDS, INTUBATED (B)(6) 2022, (B)(6) 2022 IMAGING WITH BILATERAL CONSOLIDATION, RESIDUAL HAZY OPACITIES, WHICH CONTINUED THROUGH ADMISSION. BC COLLECTED ON (B)(6) 2022 DUE TO RECURRENT APNEAS, DESATS, BRADYS. ID CONSULT FROM DR. (B)(6) ON (B)(6) 2022 INDICATED - ABSENCE OF NEUTROPHILIA AND RAPID RESOLUTION OF SYMPTOMATOLOGIC DOES SUGGEST POSSIBLE CONTAMINANT. IF THE REPEAT BC OBTAINED FOLLOWING ONLY SINGLE DOSE OF VANCOMYCIN REMAINS WITHOUT GROWTH, THIS MAY FURTHER SUGGEST POSSIBLE CONTAMINATED SPECIMEN (REPEAT BC ON (B)(6) 2022 NEGATIVE). LOW RISK FOR CNS INFECTION SUGGESTED GIVEN CLINICA

  Patient problems: Unspecified Infection

  MAUDE report 14674342 ↗
• MalfunctionJun 13, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2 : FIVE (5) PATIENTS HAVE HAD IV LINES RUPTURES. ASSESSMENT: NICU PATIENTS REQUIRING A LARGE VOLUME CONTINUOUS INFUSION (IVF, TPN ETC.), A SPACE PUMP BURETTE SET IS USED FOR THE IV ASSEMBLY. NICU STAFF HAVE OBSERVED AND RECOGNIZED FREQUENT PUMP ALARMS INDICATING AIR IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674341 ↗
• MalfunctionJun 13, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 4 : FIVE (5) PATIENTS HAVE HAD IV LINES RUPTURES. ASSESSMENT: NICU PATIENTS REQUIRING A LARGE VOLUME CONTINUOUS INFUSION (IVF, TPN ETC.), A SPACE PUMP BURETTE SET IS USED FOR THE IV ASSEMBLY. NICU STAFF HAVE OBSERVED AND RECOGNIZED FREQUENT PUMP ALARMS INDICATING AIR IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674340 ↗
• MalfunctionNov 16, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER STATED WHEN THE NURSES WERE SETTING UP/PRIMING THE IV SET, THERE WAS DIFFICULTY GETTING FLUID TO FLOW INTO THE SET. ANOTHER IV SET WAS RETRIEVED AND THE SAME INCIDENT OCCURRED. THE NURSES THEN NOTICES A PIECE OF CLEAR PLASTIC, APPROXIMATELY 1/4" LONG THAT WAS STUCK INSIDE OF THE TUBING. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080240 ↗
• MalfunctionNov 16, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER STATED WHEN THE NURSES WERE SETTING UP/PRIMING THE IV SET, THEY WAS DIFFICULTY GETTING FLUID TO FLOW INTO THE SET. ANOTHER IV SET WAS RETRIEVED AND THE SAME INCIDENT OCCURRED. THE NURSES THEN NOTICES A PIECE OF CLEAR PLASTIC, APPROXIMATELY 1/4" LONG THAT WAS STUCK INSIDE OF THE TUBING. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080195 ↗