Alaris, VersaSafe 2120-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613203012690), received between Jun 27, 2019 and Dec 19, 2019 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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 ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 11, 2019Material Separation; Material Separation

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "NURSE INVOLVED IN PREVIOUS INCIDENT IN WHICH SHE WAS SPRAYED WITH CHEMOTHERAPY, WAS SHOWING A COLLEAGUE WHAT HAPPENED WITH HER EVENT SHE TOOK A NEW PACKAGE OF PRIMARY TUBING FROM THE CLEAN SUPPLY ROOM AND OPENED IT TO DEMONSTRATE HER ACTIONS AGAIN, THE TUBING DISCONNECTED IT APPEARS AS THOUGH THIS TUBING COMES DISCONNECTED VERY EASILY."

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

  MAUDE report 9304712 ↗
• MalfunctionOct 22, 2019Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE STAFF EXPERIENCED UNSPECIFIED AMOUNT OF SETS LEAKING DURING A STAFF MEETING .ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: No Information

  MAUDE report 9221758 ↗
• MalfunctionOct 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED MULTIPLE EVENTS IN WHICH THE TUBING SETS SEPARATED.

  Patient problems: No Information

  MAUDE report 9214445 ↗
• MalfunctionOct 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED MULTIPLE EVENTS IN WHICH THE TUBING SETS SEPARATED.

  Patient problems: No Information

  MAUDE report 9214443 ↗
• MalfunctionOct 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED MULTIPLE EVENTS IN WHICH THE TUBING SETS SEPARATED.

  Patient problems: No Information

  MAUDE report 9214433 ↗
• MalfunctionOct 15, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE RN WAS HOLDING THE INFANT PATIENT WHILE THE BABY WAS ATTACHED TO THE TUBING SET INFUSING AN UNSPECIFIED MEDICATION VIA A CENTRAL LINE, WHEN THE TUBING SET UNINTENTIONALLY DISCONNECTED AT CONNECTION TO THE BD BLUE THREADED LOCK CANNULA. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193596 ↗
• MalfunctionOct 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE RN WAS PRIMING THE TUBING SET IN THE MEDICATION ROOM WHEN THE TUBING SET SEPARATED AT THE UPPER FITMENT. ALTHOUGH REQUESTED, NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. HOWEVER, IT WAS CONFIRMED DURING FOLLOW UP THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9193584 ↗
• MalfunctionOct 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE RN PRIMED THE TUBING SET AND INITIATED THE INFUSION OF AN UNSPECIFIED MEDICATION. APPROXIMATELY (10) MINUTES LATER, THE RN WAS CALLED TO THE PATIENT'S ROOM BY THE PATIENT'S MOTHER AND FOUND THAT THE TUBING SET HAD SEPARATED AT THE UPPER FITMENT. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192821 ↗
• MalfunctionJul 2, 2019Material Separation; Material Separation

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "INITIATED PATIENT INFUSION REGISTERED NURSE (RN) RESPONDED TO ALARM ON ALARIS PUMP "AIR IN LINE". RESOLVED ISSUE AND RESTARTED THE PUMP. PUMP ALARMED "AIR M LINE" FOR THE SECOND TIME RN CHECKED IV TUBING AND AT THAT TIME THE IV TUBING DETACHED FROM THE PLASTIC CONNECTION AT THE CHAMBER PORTION OF THE TUBING." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. IT WAS REPORTED DARATUMUMAB/SALINE WAS INITIATED AT AN UNSPECIFIED RATE. THE DEVICE ALARMED FOR AIR IN LINE, THE USER NOTICED THAT THE TUBING SEPARATED AT THE LOWER FITMENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM AS THE FLUIDS DID NOT GO THRU THE LENGTH OF THE TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755412 ↗
• MalfunctionJul 2, 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, "WHEN PRIMING THE IV TUBING TO START IMMUNOTHERAPY THE TUBING BECAME DISCONNECTED AT THE HUB WHERE IT WOULD BE PLACED IN THE ALARIS PUMP, WHEN REMOVING THE HARD BLUE PLASTIC THAT PROTECTS THE TUBING." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. IT WAS REPORTED THAT THE SET LEAK DUE TO SEPARATION AT THE SILICONE SEGMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753231 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT THERE WAS TUBING BREAKAGE BELOW THE BLUE PLASTIC PIECE WHEN LOADED INTO THE CHANNEL.

  Patient problems: No Information

  MAUDE report 8742291 ↗