Infusomat® 362035Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 04046964699047), received between Nov 12, 2024 and Jun 23, 2026 — classified as 1 injury, 153 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (131 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 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: EVENT 3: DETAILS OF COMPLAINT (REPORTED ISSUE): "MULTIPLE AIR IN LINE ALARMS." INCIDENT DETAILS "ATTEMPTING TO CHANGE VASOPRESSIN BAG AND LINE. MULTIPLE AIR IN LINE ALARMS, HAD TO SWITCH TUBING X 3, AND PUMPS X 2 IN ORDER TO GET AIR IN LINE ALARM TO STOP. NO VISIBLE AIR. TIME COMMITMENT WITH CRITICALLY ILL PATIENT. NURSE CALLED IN EDUCATOR TO TROUBLESHOOT AFTER FOLLOWING ALL ESTABLISHED TROUBLESHOOTING STEPS WITHOUT SUCCESS TO TEND TO URGENT PATIENT NEEDS. ENTIRE BAG OF VASOPRESSIN WASTED WITH MULTIPLE PRIMING ATTEMPTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596142 ↗
• MalfunctionJun 23, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILS OF COMPLAINT (REPORTED ISSUE): "MULTIPLE AIR IN LINE ALARMS." INCIDENT DETAILS "ATTEMPTING TO CHANGE VASOPRESSIN BAG AND LINE. MULTIPLE AIR IN LINE ALARMS, HAD TO SWITCH TUBING X 3, AND PUMPS X 2 IN ORDER TO GET AIR IN LINE ALARM TO STOP. NO VISIBLE AIR. TIME COMMITMENT WITH CRITICALLY ILL PATIENT. NURSE CALLED IN EDUCATOR TO TROUBLESHOOT AFTER FOLLOWING ALL ESTABLISHED TROUBLESHOOTING STEPS WITHOUT SUCCESS TO TEND TO URGENT PATIENT NEEDS. ENTIRE BAG OF VASOPRESSIN WASTED WITH MULTIPLE PRIMING ATTEMPTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596129 ↗
• MalfunctionJun 23, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILS OF COMPLAINT (REPORTED ISSUE): "MULTIPLE AIR IN LINE ALARMS." INCIDENT DETAILS "ATTEMPTING TO CHANGE VASOPRESSIN BAG AND LINE. MULTIPLE AIR IN LINE ALARMS, HAD TO SWITCH TUBING X 3, AND PUMPS X 2 IN ORDER TO GET AIR IN LINE ALARM TO STOP. NO VISIBLE AIR. TIME COMMITMENT WITH CRITICALLY ILL PATIENT. NURSE CALLED IN EDUCATOR TO TROUBLESHOOT AFTER FOLLOWING ALL ESTABLISHED TROUBLESHOOTING STEPS WITHOUT SUCCESS TO TEND TO URGENT PATIENT NEEDS. ENTIRE BAG OF VASOPRESSIN WASTED WITH MULTIPLE PRIMING ATTEMPTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596085 ↗
• MalfunctionJun 11, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: "MULTIPLE PERSISTENT BUBBLE ALARMS. BUBBLES CLEARED WITH DIFFERENT METHODS MULTIPLE TIMES. PUMP CHANGED TWICE. TUBING FINALLY CHANGED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469676 ↗
• MalfunctionMay 27, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): " ALMOST IMMEDIATELY THE PUMP STARTED ALARMING FOR AIR, RN HAD CLAMPED TUBE AND THEN REMOVED THE TUBING FROM PUMP. WHEN REMOVING THE TUBING FROM PUMP THE LINE SEPARATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301286 ↗
• MalfunctionMay 26, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "MULTIPLE ALARMS FOR AIR IN THE LINE. UNABLE TO GET FULL DOSE ADMINISTERED TO THE PATIENT DUE TO LOSS OF MEDICATION WHEN REMOVING AIR BUBBLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280498 ↗
• MalfunctionMay 24, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): " ALMOST IMMEDIATELY THE PUMP STARTED ALARMING FOR AIR, RN HAD CLAMPED TUBE AND THEN REMOVED THE TUBING FROM PUMP. WHEN REMOVING THE TUBING FROM PUMP THE LINE SEPARATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25266967 ↗
• MalfunctionMay 14, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "IV TUBING CONTINUALLY SAYING AIR IN LINE. DISCONNECTED AND PRIMED TUBING WITH 5ML PER PUMP SETTINGS. DID NOT RESOLVE ISSUE. TUBING TAKEN OUT OF PUMP AND REINSERTED. DID NOT RESOLVE ISSUE." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179371 ↗
• MalfunctionApr 7, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: FENTANYL INFUSION ALARMING FOR AIR". WHEN ASSESSED MINIMAL FINE BUBBLES PRESENT. DESPITE PRIMING THE TUBING OR TAPPING BUBBLES AWAY FROM PUMP ALARMS PERSISTED. USER CHANGED TUBING TWICE DURING SHIFT WHICH DISRUPTED SEDATION." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799396 ↗
• MalfunctionMar 12, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: RN NOTICED MORE THAN 3 AIR BUBBLES IN THE HEPARIN TUBING CONNECTED TO THE WHITE LUMEN OF THE PATIENT'S 2.6 FR PICC. RN DISCONNECTED THE IV TUBING FROM THE PATIENT, ORDERED NEW HEPARIN FROM PHARMACY AND PREPARED NEW TUBING FOR THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578544 ↗
• MalfunctionJan 14, 2026Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AIR BUBBLES CAUSING PUMP TO STOP INFUSING AND PT BP DROPPING. ALARM EVENTS AIR IN LINE - NOT VISIBLE AND UNRESOLVED. IMPACT TO PATIENT: VITAL SIGNS COMPROMISED. ACTION(S) TAKEN FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), OTHER. MEDICATION / FLUID NOREPINEPHRINE. IV RATE 0.18MCG/KG/MIN.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24067603 ↗
• MalfunctionJan 14, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: CONTINUOUS AIR IN LINE ALARM, UNABLE TO RESOLVE. TOOK TUBING OUT OF PUMP, VISUALLY INSPECTED FOR AIR. REPRIMED TUBING (DETACHED FROM PATIENT). NOTICED THAT AIR WAS BEING DRAWN INTO THE LINE FROM SOMEWHERE. TOOK TUBING OUT OF THE PUMP. TUBING SEVERED/DISCONNECTED AT THE WHITE CONNECTOR WHERE TUBING IS CONNECTED TO PUMP. THIS IS WHERE AIR WAS ENTERING THE LINE FROM. IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, RISK FOR INFECTION / INTRODUCTION OF CONTAMINANTS, UNDER DOSING OF ORDERED MEDICATION / FLUIDS, OTHER. OTHER PATIENT IMPACT SEVERED/DISCONNECTION IN LINE MEANT THAT AIR WAS BEING DRAWN INTO THE LINE FROM THE BREAK IN TUBING. ACTION(S) TAKEN FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT), OTHER. OTHER ACTIONS TAKEN REMOVED TUBING AND REPRIMED AFTER REALIZING THAT THE TUBING WAS SEVERED AT THE WHITE CONNECTION PORT. MEDICATION / FLUID FENTANYL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066992 ↗
• MalfunctionDec 29, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AIR BUBBLES NOTED. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905214 ↗
• InjuryDec 19, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: END USER ATTEMPTED TO FIX ISSUE IN ALL WAYS THAT HAVE BEEN SPECIFIED IN PAST BY EDUCATORS AND B BRAUN STAFF. ATTEMPTED TO REPRIME LINE, FLICK OUT BUBBLES, CLEANSE AIR SENSOR WITH ALCOHOL SWAB, CHANGED PUMPS, AND FINALLY AFTER CHANGING TO A SECOND NEW LINE STOPPED BEEPING. PATIENT IN FOR STATUS EPILEPTICUS, IN TIME THAT IT TOOK WRITER TO COMPLETE ALL METHODS TO TROUBLE SHOOT, PATIENT BEGAN TO SHOW SIGNS OF SEIZING (ARM TWITCHING, DECEREBRATE POSTURING). USER HAD TO GIVE 2MG PRN IV MIDAZOLAM TO SETTLE PATIENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 23855280 ↗
• MalfunctionNov 15, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: MGSO4 4G IV OVER 4 HOURS ORDERED, WRITER SET UP IN NEW PORT LESS TUBING AND KEPT ALARMING FOR AIR IN LINE. TOOK LINE OUT OF PUMP TO CHECK FOR AIR, (NONE NOTED) HAD TO ATTEND TO THIS ALARM X3 TIMES. MAGNESIUM PLACED INTO ANOTHER 2 PUMPS, CONTINUES TO ALARM AIR IN LINE; CHANGED TUBING AND NO FURTHER ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23563875 ↗
• MalfunctionNov 14, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): EDUCATOR FILLING THE REPORT. PATIENT TRANSFERRED FROM THE OPERATING ROOM TO THE UNIT ALARM IDENTIFIED WHEN PATIENT SETTLED INTO A ROOM. NURSE ATTEMPTED DOING ALL OF THE TIPS TO RESOLVE AIR IN THE LINE. AIR ALARM WOULD CONTINUE TO ALARM. NURSE ATTEMPTED RESOLVING MORE THAN 5 TIMES WITH THE SAME OUTCOME. EVENTUALLY CHANGED THE TUBING AND THE ISSUE RESOLVED. IMPACT TO PATIENT: INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B. BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION / FLUID RINGERS LACTATE. IV RATE 100 ML/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554755 ↗
• MalfunctionNov 12, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: ONGOING AIR IN LINE ALARM. MEDICATION NEVER INFUSED DUE TO ALARMS. MD BOLUSED PT WITH NOREPINEPHRINE AT THE BEDSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532079 ↗
• MalfunctionOct 30, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE - NOT VISIBLE AND UNRESOLVED.". IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B. BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT), OTHER. MEDICATION / FLUID KP04 30MMOL. IV RATE 93ML/HOUR. OTHER DETAILS THIS IS A HIGH ALERT MEDICATION, IN WHICH THE PATIENT REQUIRES ALL OF THE MEDICATION THAT IS IN THE SUPPLIED BAG. ALL OF THE B BRAUN TROUBLE SHOOTING INTERVENTIONS WERE UTILIZED. NOT ONLY IS IT DELAY IN MEDICATION ADMINISTRATION, TOOK AN ADDITIONAL 2-3 HOURS OF ADDITIONAL TIME, IT IS ALSO A HEAVY AMOUNT OF TIME IN WHICH NURSING HAD TO SPEND PROBLEM SOLVING, WHILE PROVIDING CARE TO AN ADDITIONAL 6 PATIENTS AND ASSISTING WITH ALL THE CARE NEEDS OF THE UNIT. AS THE NURSE ADMINISTERING THE MEDICATION, WE WERE IN THE ROOM MINIMALLY 6-10 TIMES AN HOUR RESPONDING TO PUMP ALARMS. THUS, DELAYING THE CARE OF OTHER PATIENTS. THIS WAS ALSO VERY DISRUPTIVE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426953 ↗
• MalfunctionOct 29, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE: NOT VISIBLE AND UNRESOLVED." IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, RISK FOR INFECTION/INTRODUCTION OF CONTAMINANTS, UNDER DOSING OF ORDERED MEDICATION/FLUIDS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B. BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION/FLUID POTASSIUM PHOSPHATE 30 MMOL. IV RATE 111.6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23419428 ↗
• MalfunctionOct 24, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "NOT COMPATIBLE WITH B BRAUN PUMP AND CONTINUOUSLY BEEPING FOR AIR WHEN NO AIR IN LINE." PATIENT RUNNING K PHOS TO REPLACE POTASSIUM OF 2.5. LINE CONTINUOUSLY BEEPING AIR DESPITE USER ATTEMPTING ALL LISTED TROUBLESHOOTING MEASURES AS PREVIOUSLY RECOMMENDED. DUE TO HAVING TO PRIME LINE THROUGH MULTIPLE TIMES AS WELL AS EVENTUALLY SWITCHING TUBING, APPROXIMATELY 40CC OF MEDICATION WASTED WHEN VERY IMPORTANT TO PATIENT ELECTROLYTE BALANCE. OTHER PRODUCT PROBLEM NOT COMPATIBLE WITH B BRAUN PUMP AND CONTINUOUSLY BEEPING FOR AIR WHEN NO AIR IN LINE. PT NOT RECEIVING FULL AMOUNT OF MEDICATION NEEDED TO REPLACE CRUCIAL ELECTROLYTES. IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, UNDER DOSING OF ORDERED MEDICATION / FLUIDS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION / FLUID POTASSIUM PHOSPHATE 30MMOL. IV RATE 93ML/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384001 ↗
• MalfunctionOct 17, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "B-BRAUN PUMPS ALARMING FOR AIR IN LINE, LINES REPRIMED, NO AIR IN LINE PER 2 NURSE VISUALLY CHECKING, LINES CHANGED, STILL ALARMING, PUMPS CHANGED. FOR A FENTANYL INFUSION AND NS PUSH INFUSION." IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT), OTHER. MEDICATION / FLUID NS IV RATE 15CC/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322463 ↗
• MalfunctionOct 16, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE - NOT VISIBLE AND UNRESOLVED." IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT), OTHER. MEDICATION / FLUID FENTANYL INFUSION. IV RATE 50MCG/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23313925 ↗
• MalfunctionOct 15, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE - NOT VISIBLE AND UNRESOLVED". "CAUSING ALARM ON PUMP TO SAY AIR BUBBLE". IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, UNDER DOSING OF ORDERED MEDICATION / FLUIDS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED. MEDICATION / FLUID K PHOSPHATE. IV RATE OVER 6 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300660 ↗
• MalfunctionSep 12, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MULTIPLE AND CONSISTENT AIR IN LINE ALARMS THROUGHOUT SHIFT ON LINES RUNNING HIGH DOSE NOREPINEPHRINE, VASOPRESSIN, EPINEPHRINE, FENTANYL, NORMAL SALINE. ACTUAL AIR IN LINE PRESENT AND HAVING TO BE PRIMED THROUGH OR TAPPED OUT. BACK UP LINES IN PLACE AND BEING USED BUT ALSO DEVELOPING AIR IN LINE THEMSELVES. DUE TO PATIENT'S UNSTABLE CONDITION AND ABSOLUTE RELIANCE ON THESE MEDICATIONS, REQUIRING NURSE AT BEDSIDE AT ALL TIMES TO TROUBLESHOOT ALARMS. IMPACT TO PATIENT: EMOTIONAL DISTRESS, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, VITAL SIGNS COMPROMISED. ACTION(S) TAKEN FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR. MEDICATION / FLUID NOREPINEPHRINE. IV RATE 0.65 MCG/KG/MIN.

  Patient problems: Distress; Hemodynamic instability

  MAUDE report 23038079 ↗
• MalfunctionSep 12, 2025Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: ALARM EVENTS AIR IN LINE - NOT VISIBLE AND UNRESOLVED. IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, UNDER DOSING OF ORDERED MEDICATION / FLUIDS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION / FLUID NORMAL SALINE. IV RATE 5ML/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038040 ↗