Alaris 2200-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613203012638), received between Jul 18, 2018 and Apr 16, 2021 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

2 FDA recall records 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 ↗

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 problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2021Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT AS LVP 20D DEHP LEAKED AND HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFUSION LINE DIDN'T CLAMP AUTOMATICALLY WHEN IT WAS REMOVED FROM PUMP. DETAILED INCIDENT DESCRIPTION: NURSE REMOVED LINE FROM PUMP. IT DIDN'T CLAMP AUTOMATICALLY. LINE CONTINUED TO FREE FLOW. NURSE WAS ABLE TO REPLICATE THE INCIDENT ONCE MORE WITH THE SAME LINE, BUT COULDN'T DO IT AGAIN A THIRD TIME, SO INCIDENT APPEARS TO BE INTERMITTENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682600 ↗
• MalfunctionDec 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP 20D DEHP LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2200-0500 BATCH NO: 17017286 IT WAS REPORTED THAT THERE WAS AN INCIDENT/S WITH DEFECTIVE ALARIS TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11092807 ↗
• MalfunctionDec 9, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT AS LVP 20D DEHP HAD A FAULTY VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2200-0500, BATCH NO: UNKNOWN IT WAS REPORTED THAT THE TUBING SET HAD A FAULTY VALVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10976665 ↗
• MalfunctionAug 3, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE GEM V/NV PRIMARY 20DP EXPERIENCED AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE AIR IN LINE ALARMED AFTER THE PRIMING OF A D10.45NS IV SOLUTION AND PLACING THE TUBING INTO THE PUMP. THE RN LOOKED AT THE TUBING COULDN'T FIND ANY AIR - SHE ATTEMPTED A SECOND TIME AND STILL HAD THE "AIR IN LINE"ALARM. THEY ENDED UP REMOVING THE TUBING AND REPRIMING WITH A NEW TUBING AND NO AIR IN LINE ISSUES AFTER. TUBING SENT TO BIOMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359816 ↗
• MalfunctionJul 28, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GEM V/NV PRIMARY 20DP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PREVIOUSLY WAS ONLY PHARMACY TUBING ISSUE BUT ONE OF THE TUBING¿S THAT MY DEPARTMENT HAD ORDERED WAS FOUND LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335678 ↗
• MalfunctionMar 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING A SITE VISIT IT WAS REPORTED THAT THE SAFETY CLAMP DID NOT ENGAGE WHEN IT WAS REMOVED FROM THE DEVICE. THE CLINICIAN STATED,"THE ¿SAFETY CLAMP DID NOT ACTIVATE¿ AND THE ROLLER CLAMP WAS NOT ENGAGED. NS [NORMAL SALINE] FLOWED OUT OF TUBING." THE CLINICIAN WAS EXPOSED TO THE NS INSIDE THE TUBING SET. THIS EVENT OCCURRED ON THE OUTPATIENT ONCOLOGY UNIT. THE TUBING WAS NOT CONNECTED TO THE PATIENT. THERE WAS NO PATIENT HARM. THE PUMP AND THE TUBING WERE NOT SEQUESTERED. TUBING REF#2200-0500.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868364 ↗
• MalfunctionMar 10, 2020False Alarm; False Alarm

  IT WAS REPORTED THAT THE PUMP ALARMED ¿AIR IN LINE¿, BUT AFTER TROUBLESHOOTING, NO AIR IN LINE WAS FOUND. THE NURSE STATED THAT THE PATIENT CAME UP FROM THE OR NEEDING IV FLUIDS. THE NURSE SPIKED AND HUNG NEW IV FLUIDS WITH A NEW PRIMARY TUBING SET. THE BLUE IV PUMP MODULE GAVE AN "AIR IN LINE" MESSAGE. THE IV TUBING FLUIDS WERE SWITCHED TO A TOTAL OF (3) BLUE IV PUMP MODULES THAT ALL GAVE THE SAME AIR-IN-LINE ERROR MESSAGE(S). THE NURSE SPIKED IV FLUIDS WITH A NEW PRIMARY SET, WHICH THEN WORKED ON THE IV PUMP WITHOUT ANY ERROR MESSAGE. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT AND/OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9811442 ↗
• MalfunctionFeb 19, 2020Break; Break

  IT WAS REPORTED FROM UNIT HORVITZ 4 THAT THE NURSE WAS SPIKING A BAG OF D10/NORMAL SALINE 0.25 WHEN THE TUBING SET SPIKE BROKE OFF. ALTHOUGH THERE WAS A DELAY IN MEDICATION THERAPY IN ORDER FOR A NEW IV BAG TO BE PREPARED, THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9725650 ↗
• MalfunctionNov 23, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING SET WAS "PUNCTURED", AND CAUSED NORMAL SALINE TO LEAK ONTO THE CLINICIANS DURING PRIMING, THEREFORE; THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER FURTHER STATED, THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE CLINICIANS FROM THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9366841 ↗
• MalfunctionNov 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING SEPARATED. IT WAS CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO USER HARM.

  Patient problems: No Patient Involvement

  MAUDE report 9363838 ↗
• MalfunctionNov 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PHARMACY FOUND THAT THE TUBING SET LEAKED DURING PRIMING WITH (NS) NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WIT THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9357097 ↗
• InjuryNov 4, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE TUBING SET WAS IN USE ON A NEONATAL PATIENT IN THE NICU, WHEN THE BEDSIDE NURSE NOTED LEAKING FROM THE TUBING SET AT THE POINT OF CONNECTION TO THE UPPER FITMENT. WHEN THE TUBING WAS REMOVED AND DISCONNECTED FROM THE PATIENT, THE CONNECTION OF THE TUBING AND THE UPPER FITMENT WAS CHECKED BY LIGHTLY PULLING ON THE TUBING WHICH CAUSED THE TUBING SET TO EASILY SEPARATE FROM THE UPPER FITMENT. THE CUSTOMER LATER STATED THAT THE NEONATE PATIENT HAD A POSITIVE BLOOD CULTURE WITHIN 48 HOURS OF THE EVENT (CLABSI) REQUIRING ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 9276463 ↗
• MalfunctionApr 5, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE IV TUBING SET HAD A HOLE IN THE BOTTOM PORTION OF THE SILICONE SEGMENT THAT CAUSED APPROXIMATELY ONE-HALF OF THE ZOSYN ANTIBIOTIC IV FLUIDS TO LEAK DURING USE ON AN ADULT PATIENT. IT WAS NOTED THAT THE TUBING SET HAD BEEN IN USE PRIOR TO THIS INFUSION WITHOUT DIFFICULTY. A NEW ANTIBIOTIC IV SOLUTION WAS OBTAINED FROM THE PHARMACY AND A NEW TUBING SET WAS USED AND THE PATIENT SUCCESSFULLY RECEIVED THE MEDICATION. THE CUSTOMER STATES THAT THERE WAS NO HARM CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489508 ↗
• MalfunctionJan 29, 2019Collapse; Obstruction of Flow; Collapse; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE IV TUBING SET IS COLLAPSING ON ITSELF WHILE INFUSING TPN VIA THE PATIENT'S CENTRAL LINE, THEREBY CAUSING THE PUMP TO ALARM OCCLUSION OR BAG EMPTY. THE CUSTOMER WAS UNABLE TO RESOLVE THE ISSUE AND HAD TO DISCARD THE BAG OF TPN AND PUT THE PATIENT ON "CLEARS" FOR THE REST OF THE NIGHT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286446 ↗
• MalfunctionDec 31, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK AT THE MALE LUER DURING AN HEPARIN INFUSION. THERE WAS NO REPORT OF PATIENT HARM. THE EVENT OCCURRED BETWEEN 11/2-12/4. ALTHOUGH REQUESTED THERE ARE NO ADDITIONAL INFORMATION ABOUT THE PATIENT, MEDICATION OR EVENT PROVIDED BY CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207119 ↗
• MalfunctionNov 20, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER HAD REPORTED SEPARATION AT THE LOWER FITMENT. THE CUSTOMER LATER REPORTED THAT IN THE NICU, APPROXIMATELY 50 MINUTES AFTER THE TUBING WAS CHANGED THE DEVICE ALARMED FOR AIR IN LINE. THE TUBING WAS CLAMPED, AND THE SET WAS REMOVED FROM THE PUMP MODULE. THE SILICONE PORTION OF THE SET WAS TAPPED TO DISPEL ANY AIR BUBBLES, AND WHEN THIS WAS DONE, THE TUBING BELOW THE PUMP SEGMENT SEPARATED. THERE WAS A FREE FLOW OF FLUID FROM THE SET. THE PORTION OF TUBING THAT WAS STILL ATTACHED TO THE INFANT WAS CLAMPED. IV FLUID AND TUBING WERE REPLACED.THE CUSTOMER QUESTIONS IF THE SET CAME UNGLUED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8090103 ↗
• MalfunctionJul 18, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING LEAKED WHILE CONNECTED TO A PATIENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7701496 ↗