Alaris 10011865Recalls & reported problems
BD Switzerland Sàrl · Extension Set, Smallbore Tubing, 0.2 Micron Low Protein Binding Filter 18 cm (7 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BD Alaris extension set is a smallbore tube used to extend intravenous lines. Of its 165 adverse event reports, 159 are malfunctions and 5 are injuries, and 1 is listed as a death. Many describe fluid or blood leaking or splashing from the set, with others describing complete blockages, cracks and air in the line. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 165
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 10885403233647), received between Jul 18, 2018 and Sep 14, 2026 — classified as 1 death, 5 injuries, 159 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (79 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak79
- Leak/Splash37
- Complete Blockage25
- Crack15
- Defective Component5
- Obstruction of Flow4
- Air/Gas in Device3
- Backflow3
Patient problems
- No Consequences Or Impact To Patient77
- No Clinical Signs, Symptoms or Conditions69
- Insufficient Information9
- No Known Impact Or Consequence To Patient6
- No Information3
- Low Blood Pressure/ Hypotension2
- Brain Injury1
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763184 ↗MalfunctionJun 8, 2026Obstruction of Flow
IT WAS REPORTED THAT BD ALARIS EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT FILTER TUBING READING DOWNSTREAM OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25437683 ↗MalfunctionApr 22, 2026Complete Blockage
IT IS REPORTED, ALARIS TUBING, OCCLUSION. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954293 ↗MalfunctionApr 20, 2026Separation Failure
IT WAS REPORTED, FILTER TUBING SLID OUT/DISCONNECTED FROM THE REST OF THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931841 ↗MalfunctionMar 20, 2026Air/Gas in Device
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24654698 ↗MalfunctionMar 19, 2026Complete Blockage
IT WAS REPORTED BY CUSTOMER THAT THEY HAD CLOGGED FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640123 ↗MalfunctionMar 18, 2026Obstruction of Flow
IT WAS REPORTED BY A CUSTOMER THAT THEY HAD A CLOGGED FILTER. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634175 ↗DeathMar 16, 2026Adverse Event Without Identified Device or Use Problem; Air/Gas in Device
IT WAS REPORTED THAT BD ALARIS EXTENSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE LARGE AMOUNT OF AIR EMBOLI. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. NNP CALLED TO BEDSIDE TO ASSESS LEFT ARM WITH ALINE. MOTTLING NOTED THROUGHOUT ARM, CHEST, AND BACK ALONG WITH DEC PERFUSION TO HAND. ALINE REMOVED. ULTRASOUNDS OBTAINED OF LUE AND HUS. LARGE AMOUNT OF AIR EMBOLI NOTED ON HUS. PT WITH WORSENING LACTATE ACIDOSIS AFTER RECEIVING MEDICATIONS AND INTUBATION. REPEAT HUS, CT, AND MRI WITH EXTENSIVE BRAIN INJURY.
Patient problems: Brain Injury
MAUDE report 24604505 ↗MalfunctionFeb 18, 2026Complete Blockage
IT IS REPORTED OCCLUSION. DESCRIPTION: RN ENTERED ROOM TO IV PUMP ALARMING DOWNSTREAM OCCLUSION. HIGH PRESSURE NOTED ON PUMP. RN CHECKED PIV SITE WITHOUT REDNESS OR SWELLING. RN DISCONNECTED IV TUBING AND FLUSHED EASILY 10ML NS WITH GOOD BLOOD RETURN. RN CHANGED FILTER ON IV TUBING AND PRESSURE LIMIT WENT DOWN. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381799 ↗MalfunctionFeb 18, 2026Complete Blockage
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381796 ↗MalfunctionJan 27, 2026Complete Blockage
IT IS REPORTED OCCLUSION. DESCRIPTION: NEW PIV [PERIPHERAL IV] PLACED ON INFANT'S LEG WITH POOR VENOUS ACCESS. 2 RNS ATTEMPTED PIV PLACEMENT THEN CONSULTED RNTS [REGISTERED NURSE TRAUMA SPECIALIST], WHO WAS UNSUCCESSFUL, THEN PLACED VAD (VASCULAR ACCESS) CONSULT. VAD RN ABLE TO PLACE PIV WITH ULTRASOUND AFTER 6 TOTAL ATTEMPTS. INFANT THEN CONNECTED TO MAINTENANCE FLUIDS. PUMP BEGAN ALARMING OCCLUDED. THIS RN FLUSHED PIV WITH NO RESISTANCE, ADDED ARM BOARD, AND RETRACED LINES WITH NO SIGN OF OCCLUSION. THIS RN THEN CALLED VAD FOR HELP TROUBLESHOOTING. ALARIS CHANNEL SWITCHED OUT AND PUMP CONTINUES TO ALARM OCCLUDED. VAD RN SUGGESTS PLACING NEW IV ON PATIENT, ASSUMING IV MAY BE OCCLUDED AT BEND OF THE KNEE. AS LAST EFFORT, THIS RN DISCONNECTS IV TUBING TO ALLOW FLUIDS TO RUN WIDE OPEN AND NOTICES FLUIDS DO NOT RUN THROUGH UNTIL DISCONNECTED FROM 0.2 FILTER. DEFECTIVE 0.2 MICRON FILTER IS THEN REPLACED AND RECONNECTED TO PATIENT WITH NO FURTHER ISSUES.
Patient problems: Insufficient Information
MAUDE report 24189687 ↗MalfunctionJan 22, 2026Obstruction of Flow
PUMP ALARMING DOWNSTREAM OCCLUSION. PIV FLUSHED WITH EASE, ABLE TO GET BLOOD RETURN, IV SITE ASYMPTOMATIC, FILTER CHANGED OUT WITH NEW FILTER BUT SAME TYPE OF FILTER. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145452 ↗MalfunctionJan 21, 2026Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING RAPID REMICADE INFUSION BLOCKED FILTER ON TUBING CAUSING LINE TO ALARM OCCLUSION. ALL TROUBLE SHOOTING DONE BEFORE CHANGING FILTER AND MED INFUSED ONCE FILTER CHANGED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE RATE OF THE INFUSION? 100ML/HOUR FOR FIRST 15MIN AND IF TOLERATED 300ML/HOUR FOR REMAINDER OF INFUSION. HOW LONG INTO THE INFUSION DID OCCLUSION OCCUR? UNSURE FROM EVENT REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24137429 ↗MalfunctionJan 2, 2026Complete Blockage
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT PT INFUSION PUMP BEEPING DOWNSTREAM OCCLUSION, UPON ASSESSMENT NOTICED FILTER WAS THE ISSUE AND CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23950113 ↗MalfunctionDec 17, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY A CUSTOMER THAT THEY COULD NOT MOVE FLUID THROUGH THE BD EXTENSION AND THERE MUST BE A MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835086 ↗MalfunctionDec 17, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY A CUSTOMER THAT THEY COULD NOT MOVE FLUID THROUGH THE BD EXTENSION AND THERE MUST BE A MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835085 ↗MalfunctionDec 16, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824764 ↗MalfunctionDec 16, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824762 ↗MalfunctionDec 16, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT PT WITH IV PUMP BEEPING DOWNSTREAM OCCLUSION. TROUBLE SHOOTED PUMP, THEN HAD TO CHANGE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824509 ↗MalfunctionDec 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT WHEN WRITER DID MORNING SAFETY CHECK IT NOTED THAT THE BED SHEET WAS WET. WRITER PLACED A BLUE TOWEL UNDERNEATH LINE (AS REPELLENT) TO SEE WHERE LINES WERE LEAKING (WAS NOT EASILY VISUALIZED). ALL CONNECTIONS WERE TIGHTENED AND NOTED TO BE LEAKING FROM TPN LINE WERE INSERTED INTO TPN FILTER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23722902 ↗MalfunctionDec 1, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT OCCLUSION AND FILTER BLOCKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23689142 ↗MalfunctionOct 27, 2025Complete Blockage; Complete Blockage
MalfunctionOct 23, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE BD ALARIS PUMP INFUSION SET HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FILTER ATTACHMENTS DISPELLING AIR FROM THEM WHEN TILTED SIDE TO SIDE LOT NUMBER (10)25019439. 2 FILTERS TRIED WITH SAME RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372135 ↗MalfunctionAug 19, 2025Complete Blockage; Complete Blockage
MalfunctionAug 19, 2025Leak/Splash; Leak/Splash
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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