Alaris, VersaSafeRecalls & reported problems across all models

We found 10 models of Alaris, VersaSafe by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2018 and May 5, 2023 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Alaris, VersaSafe recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 19, 2026Class IOpen, Classified

   Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

   Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. May 6, 2019Class ITerminated

   An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

   Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Alaris, VersaSafe problems

Alaris, VersaSafe models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alaris, VersaSafe 2120-0500

  Set, administration, intravascular
  1 recall14 reports
• Alaris, VersaSafe 2110-0500

  Set, administration, intravascular
  1 recall1 report
• Alaris, VersaSafe 21001M-07

  Set, administration, intravascular
  9 reports
• Alaris, VersaSafe 10779313

  Set, administration, intravascular
  7 reports
• Alaris, VersaSafe 10796812

  Set, administration, intravascular
  4 reports
• Alaris, VersaSafe 10796814

  Set, administration, intravascular
  3 reports
• Alaris, VersaSafe 2177-0000

  Set, administration, intravascular
  2 reports
• Alaris, VersaSafe 10807851

  Set, administration, intravascular
  2 reports
• Alaris, VersaSafe 11275183

  Set, administration, intravascular
  1 report
• Alaris, VersaSafe 11499817

  Set, administration, intravascular
  1 report

Recent Alaris, VersaSafe adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS VERSASAFE EXTENSION SET EXPERIENCED DISCONNECTION AND LEAKED. THIS IS 2 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSTED BY USER, INTAKE ON 4/12/2023 12:48:21 AM INTAKE NOTE AFTER INSERTING A PIV AND FLUSHING THROUGH THE SLIP-TIP T-CONNECTOR, IT WAS ATTACHED AND SECURED WITH ADDITIONAL TAPE AT THE CONNECTION. APPROX 5 MINS LATER, BLOOD WAS NOTED ON THE ARMBOARD. UPON FURTHER ASSESSMENT, IT WAS DETERMINED THAT THE T-CONNECTOR HAD MIGRATED OUT SLIGHTLY AND BLOOD WAS BACKFLOWING OUT OF THE CATHETER. THE T-CONNECTOR WAS TIGHTENED AND FLUSHED, HOWEVER WHILE RETAPING, IT COULD BE SEEN FLOATING BACK OUT OF THE CATHETER. AT THIS TIME, THE NNP WAS AT BEDSIDE AND ASKED THIS RN TO UTILIZE OUR REGULAR SCREW ON TYPE OF T-CONNECTOR. THE T-CONNECTOR WAS CHANGED OUT AND THE PIV RETAPED WITH NO FURTHER ISSUES OF BLOOD LEAKING OUT. HAD I NOT BEEN AT BEDSIDE WHEN THIS HAPPENED, THE INFANT COULD HAVE LOST A LOT OF BLOOD DURING THE TIME THAT WOULD PASS BEFORE MY NEXT PIV CHECK 55 MINS LATER. IT IS A SAFETY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882186 ↗
• MalfunctionMay 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS VERSASAFE EXTENSION SET EXPERIENCED DISCONNECTION. THIS IS 1 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSTED BY USER, INTAKE ON (B)(6) 2023 2:20:05 PM. INTAKE NOTE: RN OBTAINED PIV AND HAD STARTED A BLOOD TRANSFUSION. ORDERS RECEIVED TO RETAPE THE ETT, AS RT WAS POSITIONING PATIENT TO RETAPE, RT NOTICED THE "SLIP-TIP" HAD DETACHED FROM THE CATHETER HUB. ALSO, TO NOTE, PATIENT HAD RECEIVED A BOLUS OF AN ORDERED SEDATION MEDICATION AND IT HAD NOT TAKEN EFFECT YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882182 ↗
• MalfunctionJun 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ VERSASAFE¿ EXTENSION SET EXPERIENCED SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONNECTION AT THE SPLIT SEPTUM FELL APART DURING AN INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14743924 ↗
• MalfunctionApr 20, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS VERSASAFE EXTENSION SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN NOTICED BLOOD BACKING UP IN THE TUBING AND THAT THE NEW KIND OF IV TUBING WE ARE USING BROKE. THE DISCONNECTION WAS NOT AT A SITE THAT NORMALLY COMES APART. IT WAS WHERE A NEEDLESS HUB AND THE TUBING MEET. THE TUBING SLIPPED APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164119 ↗
• MalfunctionAug 19, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SE BLD 15DP 180MF 1VS DEHP FREE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A LEAK WAS FOUND DURING THE TRANSFUSION AT THE JUNCTION AT THE INJECTION SITE FOR 2 TUBES OF THE SAME REFERENCE BUT FROM DIFFERENT BATCHES AND LAID BY 2 NURSES. DIFFERENT TO 2 DIFFERENT PATIENTS. THIS RESULTED IN LABILE BLOOD PRODUCT LOSS AND NECESSITATED A CHANGE OF TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10429206 ↗
• MalfunctionAug 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP BUR 20D 3VS SEPARATED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:1077-9313 BATCH NO: UNKNOWN. IT WAS REPORTED THAT PLASTIC CAP ON TOP OF BURETROL SEPARATED CAUSING CHEMO SPILLS. INITIAL NOTICE: WE RECENTLY BEGAN USING OUR ORIGINAL BURETROLS. WE HAVE SINCE HAD ISSUES WHERE THE PLASTIC CAP AT THE TOP OF THE BURETROL HAS COME OFF. THIS HAS HAPPENED 3 TIMES NOW IN THE LAST PAST 2 WEEKS- ALL RESULTING IN CHEMO SPILLS AND THE NEED TO PREPARE NEW DOSES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395797 ↗
• MalfunctionJun 19, 2020Break; Break

  IT WAS REPORTED THAT A MONTH PRIOR, THE PLASTIC PIECE ON TOP OF BURETTE BROKE OFF. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 10176733 ↗
• MalfunctionJun 15, 2020Break; Break

  IT WAS REPORTED FROM (B)(6) THAT ONE MONTH PRIOR THE PLASTIC PIECE ON TOP OF BURETTE HAD "BROKEN" OFF. CHEMOTHERAPY PRODUCT HAD BEEN PRIMED INTO THE TUBING BY THE PHARMACY TWO HOURS PRIOR TO THERAPY. THE CHEMOTHERAPY AGENT WAS ABOUT TO BE STARTED UNTIL THE PLASTIC PIECE BROKE OFF, SPILLING CHEMO INTO THE BAG THAT IT WAS DELIVERED IN. THIS CAUSED A 30 MINUTE DELAY IN STARTING THERAPY. THE EXPOSURE WAS CONTAINED TO THE BIOHAZARD BAG THAT THE CHEMO WAS DELIVERED IN. CHEMO STARTED APPROXIMATELY THIRTY MINUTES LATE. THERE WAS NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10155020 ↗
• MalfunctionFeb 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. IT WAS OBSERVED THAT A DROP OF FLUID WAS ACCUMULATING AT THE INJECTION PORT. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM. ALTHOUGH REQUESTED, PATIENT INFORMATION NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9726248 ↗
• MalfunctionFeb 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM. ALTHOUGH REQUESTED, CUSTOMER UNABLE TO PROVIDE PATIENT INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717602 ↗
• MalfunctionFeb 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM. ALTHOUGH REQUESTED, PATIENT INFORMATION NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717566 ↗
• MalfunctionFeb 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717428 ↗
• MalfunctionDec 19, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE PATIENT CALLED THE NURSE TO THE ROOM BECAUSE THE IV PUMP WAS LEAKING UPON INVESTIGATION, THE NURSE DISCOVERED THAT THE IV TUBING HAD BECOME DISCONNECTED INSIDE THE CHANNEL DURING BASIC INFUSION THE TUBING BECAME DISCONNECTED AT THE FIRST BLUE SITE DISTAL TO THE SPIKED 500CC BAG OF D51/2 THE WRAPPING WAS NOT ABLE TO BE LOCATED FOR THE LOT NUMBER." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED."

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9492750 ↗
• MalfunctionNov 14, 2019Break; Break

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "ALARIS PUMP IV TUBING WAS REMOVED FROM THE PACKAGE, NURSE WENT TO PRIME TUBING TO FIND THAT IT WAS BROKEN IT WAS BROKEN TOWARDS THE END OF THE LINE, NOT NEAR ANY OF THE BLUE AREAS NO ONE WAS EXPOSED, THE NURSE NOTICED IT WHEN PRIMING THE TUBING WITH NORMAL SALINE."

  Patient problems: No Patient Involvement

  MAUDE report 9324415 ↗
• MalfunctionNov 11, 2019Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "WHILE HELPING ANOTHER NURSE WITH AN IV PUMP THAT KEPT BEEPING "AIR IN LINE", THE NURSE TOOK THE TUBING OUT OF THE PUMP AND RAN HER FINGERS DOWN THE TUBING CONNECTIONS THE TUBING BECAME DISCONNECTED FROM THE MAINLINE SQUIRTING CHEMOTHERAPY ON THE NURSE'S ARMS, HANDS, FACE, CHEST, AND LEG."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304738 ↗

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