Alaris 10015817Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885403234057), received between Nov 21, 2019 and Sep 29, 2026 — classified as 1 death, 22 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935981 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935975 ↗
• MalfunctionJun 2, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OVER INFUSING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VEBATIM. IT WAS REPORTED BY CUSTOMER THAT THE PROPOFOL INFUSED QUICKER THAN EXPECTED ON A PUMP MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127865 ↗
• MalfunctionOct 30, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS MISSING A CLAMP. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT WHILE DOING NIGHTLY LINE CHANGE, NOTED THAT QUAD FUSE WAS MISSING A CLAMP ON ONE OF THE PORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570915 ↗
• MalfunctionSep 21, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED MAT# 10015817 LOT# UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT LEAK WHERE TUBING BRANCHES OFF INTO MULTIPLE TUBES. VERBATIM : RCC RECEIVED THE PHONE VIA PHONE. PIR AS ATTACHED LEAK WHERE TUBING BRANCHES OFF INTO MULTIPLE TUBES. PSR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795470 ↗
• MalfunctionSep 16, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET LEAKED FROM THE LUMEN DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOTED THAT DRIPS WERE LEAKING AROUND LUMEN AND NOT INFUSING INTO PATIENT. ATTEMPTED TO RECONNECT AND UNDER STERILE PROCESS AND AGAIN LUMEN LEAKING. YOU COULD SEE THAT THE QUAD FUSE DID NOT GOT FAR INTO THE LUMEN BUT WOULD NOT GO ANY FURTHER. HAD TO RECONNECT NEW QUAD FUSE WITH DRIPS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15435359 ↗
• MalfunctionSep 16, 2022Backflow; Backflow

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET HAD ISSUES WITH BLOOD BACKFLOW DURING THE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT WAS DUE FOR A LINE CHANGE. PT HAD NEW QUAD FUSE WITH DRIPS, UNDER STERILE TECHNIQUE DRIP LINE WAS EXCHANGED. NOTED THAT WHITE LUMEN WHICH HAD DRIPS INFUSING HAD BACKED UP WITH BLOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15435358 ↗
• DeathApr 15, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/4 FEMALE LL WAS CRACKED AND LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 10015817, BATCH/LOT #: 20095145. IT WAS REPORTED THAT THE CONNECTION ON THE EXTENSION SET WAS CRACKED AND LEAKING. VERBATIM: PATIENT UNDERWENT CARDIAC ARREST [DATE REDACTED]. PATIENT INITIALLY UNDERWENT VENTRICULAR FIBRILLATION ARREST COMPRESSIONS WERE STARTED IMMEDIATELY. PATIENT WAS NOTED HAVE A NORMAL GLUCOSE AND ISTAT BLOOD TEST SHOWED NORMAL ELECTROLYTES. PATIENT WAS GIVEN APPROXIMATELY 2 ROUNDS OF EPINEPHRINE AND ONE AMP OF BICARBONATE EMPIRICALLY. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AND THE PATIENT WAS NOTED TO GO INTO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND WAS GIVEN A LOAD OF AMIODARONE 150MG AND CONVERTED TO SINUS. PATIENT REMAINED HYPOTENSIVE ON LEVOPHED AND VASO. HE ALSO WAS PROFOUNDLY HYPOXIC AND WAS STARTED ON INHALED NITRIC OXIDE ALONG WITH MAXIMAL VENTILATOR SETTINGS WITH A POSITIVE END-EXPIRATORY PRESSURE OF 17. PATIENT'S BLOOD PRESSURE ACUTELY DROPPED TO 57/38 WITH MEAN ARTERIAL PRESSURE OF 44 AT 1720. SEVERAL RN1S WENT INTO THE ROOM, MAXED OUT LEVOPHED CURRENTLY RUNNING ON PATIENT

  Patient problems: Cardiac Arrest; Hypoxia

  MAUDE report 11674985 ↗
• MalfunctionMar 16, 2021Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED THAT THE EXT SET SMALLBORE TBG W/4 FEMALE LL HUB CRACKED AFTER CONNECTING THE TUBING, WHICH ALLOWED BLOOD TO BACK UP INTO IT AND LEAK OUT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 9 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HUB CRACKED ON MINUTES AFTER CONNECTING NEW TUBING TO THE RED LUMEN OF THE PICC TONIGHT, BLOOD BEGAN TO BACK UP IN THE TUBING AND LEAK THROUGH A CONNECTION. I IMMEDIATELY CLAMPED THE LUMEN AND ASKED FOR ASSISTANCE IN TROUBLESHOOTING. IT APPEARS THAT THERE WAS A CRACK IN THE CONNECTION BETWEEN THE QUAD FUSE AND THE PRESSURE TUBING LEADING TO THE CVP TRANSDUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499480 ↗
• MalfunctionDec 22, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/4 FEMALE LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 10015817. BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THE TUBING WAS LEAKING AT THE QUAD FUSE CONNECTION. VERBATIM: MOM NOTED WETNESS ON HER PANTS AS CHILD WAS OUT OF BED AND BROVIAC LINES WERE DRAPPED OVER MOM LEG. NICARDIPINE LINE APPEARED LEAKING AT QUAD FUSE CONNECTION SLIGHTLY. STERILE GAUZE WRAP PLACED AND SECURED WITH GTTS ORDERED TO REPLACE ALL LINES. BLOOD PRESSURE MEDICATION TITRATED THROUGHOUT THE SHIFT. MONITORING CLOSELY. NURSE APPROXIMATED ONE TO ONE AND ONE HALF MLS OF FLUID ON GAUZE PRIOR TO NEW LINE CHANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11061174 ↗
• MalfunctionDec 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/4 FEMALE LL WAS MISSING ONE OF THE PORTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 10015817 BATCH/ LOT #: UNKNOWN ( 20035145 PROVIDED LOT BUT INVALID) IT WAS REPORTED THAT THE CAP WAS MISSING ON ONE OF THE PORTS. VERBATIM: QUADFUSE TUBING WAS FOUND TO HAVE A CAP MISSING ON ONE OF THE PORTS STRAIGHT OUT OF THE STERILE PACKAGING DURING LINE SETUP. TUBING WAS NOT USED ON PATIENT. TUBING NOT SAVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10978711 ↗
• MalfunctionNov 24, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/4 FEMALE LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 10015817, BATCH/ LOT #: UKNOWN. IT WAS REPORTED THAT THE QUAD-FUSE ON THE DRIP LINE WAS LEAKING. VERBATIM: QUAD-FUSE ON DRIP LINE (INFUSING IV FLUIDS AND SEDATION MEDS) NOTED TO BE LEAKING. NO OBVIOUS CRACKS NOTED. LINE RE-TIGHTENED BUT CONTINUED TO LEAK. COMPLETE STERILE LINE CHANGE COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10891326 ↗
• MalfunctionOct 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/4 FEMALE LL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10015817 LOT NO.: UNKNOWN IT WAS REPORTED THAT THERE WAS CRACKING IN A QUADFUSE SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694542 ↗
• MalfunctionAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  UNEXPECTED RETURN WITH UNSPECIFIED FAILURE.

  Patient problems: No Information

  MAUDE report 10376266 ↗
• MalfunctionJul 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/4 FEMALE LL TUBING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10015817, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE TUBING LEAKED AT THE CONNECTION OF A QUAD-FUSE AND THE TPN FILTER AT 2:00PM. BRIEF DESCRIPTION: LEAKING CONNECTIONS ON 2 DIFFERENT GTT LINES. LINE WAS CHANGED AT 1000 FOR LEAKING LINE. LINE CHANGED AGAIN AT 1400 FOR LINE LEAKING AGAIN. BOTH LINES WERE LET UP WITH QUAD-FUSE TUBING. 1ST LINE WAS LEAKING AT THE CONNECTION OF THE QUAD-FUSE AND A MICROBORE TUBING. 2ND LINE WAS LEAKING AT THE CONNECTION OF A QUAD-FUSE AND THE TPN FILTER. BOTH QUAD-FUSES SAVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317138 ↗
• MalfunctionJul 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/4 FEMALE LL TUBING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10015817 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE TUBING LEAKED AT CONNECTION OF THE QUAD-FUSE AND A MICROBORE TUBING AT 10:00AM. BRIEF DESCRIPTION: LEAKING CONNECTIONS ON 2 DIFFERENT GTT LINES. LINE WAS CHANGED AT 1000 FOR LEAKING LINE. LINE CHANGED AGAIN AT 1400 FOR LINE LEAKING AGAIN. BOTH LINES WERE LET UP WITH QUAD-FUSE TUBING. 1ST LINE WAS LEAKING AT THE CONNECTION OF THE QUAD-FUSE AND A MICROBORE TUBING. 2ND LINE WAS LEAKING AT THE CONNECTION OF A QUAD-FUSE AND THE TPN FILTER. BOTH QUAD-FUSES SAVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317067 ↗
• MalfunctionJun 25, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/4 FEMALE LL HAD A HOLE IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10015817 BATCH NO.: UNKNOWN. IT WAS REPORTED THERE WAS A HOLE IN ONE OF THE LUMENS OF THE QUAD FUSE RESULTING IN UVC BACKING UP WITH BLOOD.

  Patient problems: Blood Loss

  MAUDE report 10196384 ↗
• MalfunctionMay 4, 2020Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  IT WAS REPORTED THAT THE QUAD FUSE TUBING SET WAS CRACKED AT THE CENTRAL VENOUS LINE (CVL). AFTER PATIENT ASSESSMENT, IT WAS NOTED THAT BLOOD AND INTRAVENOUS FLUID (IVF) WERE SEEN ON THE PATIENT'S BED. IT WAS ALSO NOTED THAT CVL WAS BACKED UP WITH BLOOD. THE STERILE DRIP LINE CHANGE WAS COMPLETED AFTER LINE WAS FLUSHED AND IVF WAS MOVED TO AN ALTERNATE SITE. THERE WERE NO ADVERSE EFFECTS CAUSE TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022658 ↗
• MalfunctionApr 28, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A TUBING CRACK WITH A LEAK. A QUADFUSE EXTENSION SET WAS IN USE ON AN UMBILICAL VENOUS CATHETER, WHEN A CRACK WITH A LEAK WAS OBSERVED AT THE "NAD." IT WAS NOTED THAT THE TUBING WAS CLAMPED OFF AND THE QUADFUSE EXTENSION SET WAS REPLACED. THE EVENT OCCURRED ON A PEDIATRIC UNIT. THERE WAS NO PATIENT HARM. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005074 ↗
• MalfunctionApr 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  UNEXPECTED RETURN _ THE IV TUBING PORT LEAKED (NICU).

  Patient problems: No Information

  MAUDE report 9992797 ↗
• MalfunctionApr 23, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A TUBING BREAK AND LEAK. DURING USE, ONE OF THE EXTENSIONS FROM THE QUADFUSE EXTENSION SET BROKE NEAR THE HUB. IT WAS NOTED THAT AFTER THE CLINICIAN UNCLAMPED THE QUADFUSE TUBING TO ADMINISTER MEDICATION; BLOOD LEAKED ONTO THE BED. IT WAS OBSERVED THAT THE QUADFUSE TUBING WAS BROKEN AND THE LINE WAS IMMEDIATELY CLAMPED. IT WAS REPORTED THAT THE OTHER THREE TUBING LINES OF THE QUADFUSE WERE STILL IN USE. NO MEDICAL OR SURGICAL INTERVENTION, NOR A CHANGE IN TREATMENT FOR THE PATIENT WAS REQUIRED AS A RESULT OF THE EVENT. THE PATIENT WAS A CHILD. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989389 ↗
• MalfunctionNov 22, 2019Break; Break

  IT WAS REPORTED FROM THE PEDIATRIC NEWBORN UNIT THAT WHILE PUTTING TOGETHER TUBING IN A STERILE FIELD FOR UVC FLUIDS TO BE INFUSED ON AN INFANT , THE NURSE NOTED THAT THE QUAD FUSE HAD A MICRO CRACK WITH AN UNEVEN SURFACE ON THE TOP OF ONE OF THE PORTS. THE NAD WOULD NOT ATTACH CORRECTLY. SO BEFORE FLUID WAS SPIKED, A NEW QUAD FUSE WAS OPENED FOR THE NURSE AND DROPPED INTO STERILE FIELD. IV TUBING WAS THEN ABLE TO BE ATTACHED CORRECTLY AND FLUIDS WERE THEN HUNG ON PATIENT.

  Patient problems: No Information

  MAUDE report 9365119 ↗
• MalfunctionNov 21, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT QUAD FUSE ATTACHED TO CENTRAL LINE BROKE AND ONE PORT LEAKED FLUID WHEN FLUSHED WITH A SYRINGE.

  Patient problems: No Information

  MAUDE report 9356357 ↗