Alaris, SmartSite 11522558Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 10885403232305), received between Apr 23, 2018 and Sep 17, 2024 — classified as 1 injury, 123 malfunctions.

The most frequently reported specific device problem is “Free or Unrestricted Flow” (35 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. Sep 11, 2025Class IOpen, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-0035-2026 · Root cause: Under Investigation by firm · 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 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Leak/Splash; Leak/Splash

  MATERIAL # 11522558 AND BATCH # 23085448, 24025573. IT WAS REPORTED BY CUSTOMER THAT THEY HAD TWO INSTANCES NOW OF TUBING LEAKING. ONE WAS WITH CHEMO AND ONE WITH IVF. IT IS LEAKING AT THE PART OF THE TUBING THAT GOES IN THE PUMP. VERBATIM: I DON¿T HAVE ALL THE INFORMATION AND I WILL GET MORE, BUT I AM OUT TOMORROW SO I WANTED TO SEND A QUICK FYI THAT WE HAVE HAD TWO INSTANCES NOW OF TUBING LEAKING. ONE WAS WITH CHEMO AND ONE WITH IVF. BELOW IS A PICTURE OF WHERE IT IS LEAKING, THE PART OF THE TUBING THAT GOES IN THE PUMP. ADDITIONAL INFORMATION: 1.AS ADVISED THE IVF TUBING WITH HOLE WAS INTEROFFICE MAILED TO ARIELLE ON 8/23. WILL THAT BE REACHING TO OUR PLANT? ONCE MY RISK MANAGEMENT DEPARTMENT IS DONE WITH THE SAMPLE, I CAN CERTAINLY SEND IT. PLEASE SEND A LABEL FOR ME TO DO SO. 2.KINDLY PROVIDE THE VALID LOT NUMBER FOR # (10)2402557. THIS LOT NUMBER SEEMS TO BE INVALID. LOT # (10)24025573.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241750 ↗
• MalfunctionSep 17, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM FYI THAT WE HAVE HAD TWO INSTANCES NOW OF TUBING LEAKING. ONE WAS WITH CHEMO AND ONE WITH IVF. BELOW IS A PICTURE OF WHERE IT IS LEAKING, THE PART OF THE TUBING THAT GOES IN THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241647 ↗
• MalfunctionMay 13, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: YOU SHOULD HAVE RECEIVED INFORMATION ABOUT AN ISSUE WITH IV TUBING LAST WEEK. I HAVE THE BD ALARIS PUMP INFUSION SET WITH BALL VALVE. THE PRODUCT HAS A BALL IN THE DRIP CHAMBER THAT PREVENTS AIR ENTERING THE LINE AS IT FORMS A SUCTION/SEAL WAS THE MEDICATION LEAVES THE DRIP CHAMBER INTO THE TUBING. ON 4/11/24 THIS TUBING WAS USED PRIMING A METHOTREXATE INFUSION BY CHEMOTHERAPY PHARMACY. THE VALVE WAS UPRIGHT BUT AIR MANAGED TO ENTER THE LINE PAST THE BALL AS IT WAS SITTING IN THE BALL VALVE AS INTENDED. NO PATIENT HARM OCCURRED AS THE NURSES INTERVENED TO ADMIN ALL THE METHOTREXATE AND THE CHEMO ERROR TASKFORCE HAS YET TO CATEGORIZE THE MIDAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306126 ↗
• MalfunctionApr 28, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 11522558. BATCH NUMBER#: 22095036. IT WAS REPORTED BY CUSTOMER THAT ISSUE HAS BEEN REPORTED REGARDING POTENTIAL LEAKING. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. OUR CUSTOMER HAS LODGED A COMPLAINT REGARDING ITEM#: 11522558, LOT#: 22095036. THE COMPLAINT IS AS FOLLOWS: PLEASE NOTE THAT AN ISSUE HAS BEEN REPORTED REGARDING POTENTIAL LEAKING OF L 135161, C # (B)(4) IV SET PUMP W/BALL 3 PORT WITH LOT NUMBER (10) 22095036. VALUE ANALYSIS HAS REQUESTED THIS ITEM AND LOT NUMBER BE PULLED FROM USE AND RETURNED TO CONCORDANCE FOR RETURN TO THE MANUFACTURER. PLEASE PROVIDE RGA FOR THE RETURN OF 601 EA OF THIS ITEM.

  Patient problems: Insufficient Information

  MAUDE report 19199069 ↗
• MalfunctionMar 7, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: NOW THAT THE BACK ORDER OF OUR STANDARD BALL SET PUMP TUBING HAS BEEN CORRECTED WE ARE AGAIN EXPERIENCING AIR IN LINE ISSUES. NOW THAT THE BACK ORDER OF OUR STANDARD BALL SET PUMP TUBING HAS BEEN CORRECTED WE ARE AGAIN EXPERIENCING AIR IN LINE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862386 ↗
• MalfunctionJan 2, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM; ON PREVIOUS SITE VISITS, CPC DETERMINED THAT THE PRACTICE IN THE INFUSION CENTER OF OVER PROGRAMMING THE VTBI (VOLUME TO BE INFUSED) TO INCLUDE THE FLUSH WAS A CONTRIBUTING FACTOR TO THE FAILURE OF THE BALL SEATING PROPERLY. A VACUUM IS CREATED WHICH CAN POTENTIALLY PREVENT THE BALL FROM COMPLETELY SEALING THE VALVE. IF THERE IS A DEFORMITY IN THE DRIP CHAMBER THIS CAN ALSO LEAD TO THE BALL NOT SEATING PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 18423491 ↗
• MalfunctionNov 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: DESCRIPTION OF ISSUE: "WHILE INVESTIGATING AN AIR EMBOLISM INCIDENT THAT OCCURRED IN THE EMERGENCY DEPARTMENT ON 10/14/23, A FEW STAFF MEMBERS REPORTED THIS TUBING WOULD OCCASIONALLY LEAK IN THE AREA OF THE CHAMBER/SPIKE. WE DO NOT HAVE ANY TUBING AT THIS TIME¿WE HAVE REQUESTED STAFF SEQUESTER ANY THAT DOES LEAK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196280 ↗
• MalfunctionNov 7, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD AIR IN THE LINE, THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THANK SO MUCH FOR TAKING THE TIME TO TALK TO ME TODAY. AS PER OUR CONVERSATION: YOU HAVE A GENERALIZED COMPLAINT OF AIR-IN-LINE WITH THE IV SET 11522558 WHICH IS THE BD BALL/VALVE SET . THERE HAVE BEEN MULTIPLE INTERNAL REPORTS (UNKNOWN NUMBER OF EVENTS) OF THE BALL FAILING TO SEAT PROPERLY AND AIR GETTING DOWN INTO THE LINE. THERE IS NOT A LOT NUMBER AVAILABLE FOR THESE EVENTS AND THERE WAS NO PATIENT HARM RELATED TO THE AIR IN LINE. AN UNKNOWN NUMBER OF THESE EVENTS HAVE HAPPENED IN AN OUTPATIENT INFUSION CENTER. PLEASE CONFIRM THAT THIS INFORMATION REGARDING THE REPORTED ISSUE OF AIR IN LINE FROM BALL VALVE NOT SEATING PROPERLY IS ACCURATE AND THAT THERE IS NOT ANY OTHER INFORMATION AVAILABLE. ON PREVIOUS SITE VISITS, CPC DETERMINED THAT THE PRACTICE IN THE INFUSION CENTER OF OVER PROGRAMMING THE VTBI (VOLUME TO BE INFUSED) TO INCLUDE THE FLUSH WAS A CONTRIBUTING FACTOR TO THE FAILURE OF THE BALL SEATING PROPERLY. A VACUUM IS CREATED WHICH CAN POTENTIALLY PREVENT THE BALL FROM COMPLETELY SEALING THE VALVE. IF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088581 ↗
• MalfunctionNov 7, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THANK SO MUCH FOR TAKING THE TIME TO TALK TO ME TODAY. AS PER OUR CONVERSATION: YOU HAVE A GENERALIZED COMPLAINT OF AIR-IN-LINE WITH THE IV SET 11522558 WHICH IS THE BD BALL/VALVE SET . THERE HAVE BEEN MULTIPLE INTERNAL REPORTS (UNKNOWN NUMBER OF EVENTS) OF THE BALL FAILING TO SEAT PROPERLY AND AIR GETTING DOWN INTO THE LINE. THERE IS NOT A LOT NUMBER AVAILABLE FOR THESE EVENTS AND THERE WAS NO PATIENT HARM RELATED TO THE AIR IN LINE. AN UNKNOWN NUMBER OF THESE EVENTS HAVE HAPPENED IN AN OUTPATIENT INFUSION CENTER. PLEASE CONFIRM THAT THIS INFORMATION REGARDING THE REPORTED ISSUE OF AIR IN LINE FROM BALL VALVE NOT SEATING PROPERLY IS ACCURATE AND THAT THERE IS NOT ANY OTHER INFORMATION AVAILABLE. ON PREVIOUS SITE VISITS, CPC DETERMINED THAT THE PRACTICE IN THE INFUSION CENTER OF OVER PROGRAMMING THE VTBI (VOLUME TO BE INFUSED) TO INCLUDE THE FLUSH WAS A CONTRIBUTING FACTOR TO THE FAILURE OF THE BALL SEATING PROPERLY. A VACUUM IS CREATED WHICH CAN POTENTIALLY PREVENT THE BALL FROM COMPLETELY SEALING THE VALVE. IF THERE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088487 ↗
• MalfunctionNov 7, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THANK SO MUCH FOR TAKING THE TIME TO TALK TO ME TODAY. AS PER OUR CONVERSATION: YOU HAVE A GENERALIZED COMPLAINT OF AIR-IN-LINE WITH THE IV SET 11522558 WHICH IS THE BD BALL/VALVE SET . THERE HAVE BEEN MULTIPLE INTERNAL REPORTS (UNKNOWN NUMBER OF EVENTS) OF THE BALL FAILING TO SEAT PROPERLY AND AIR GETTING DOWN INTO THE LINE. THERE IS NOT A LOT NUMBER AVAILABLE FOR THESE EVENTS AND THERE WAS NO PATIENT HARM RELATED TO THE AIR IN LINE. AN UNKNOWN NUMBER OF THESE EVENTS HAVE HAPPENED IN AN OUTPATIENT INFUSION CENTER. PLEASE CONFIRM THAT THIS INFORMATION REGARDING THE REPORTED ISSUE OF AIR IN LINE FROM BALL VALVE NOT SEATING PROPERLY IS ACCURATE AND THAT THERE IS NOT ANY OTHER INFORMATION AVAILABLE. ON PREVIOUS SITE VISITS, CPC DETERMINED THAT THE PRACTICE IN THE INFUSION CENTER OF OVER PROGRAMMING THE VTBI (VOLUME TO BE INFUSED) TO INCLUDE THE FLUSH WAS A CONTRIBUTING FACTOR TO THE FAILURE OF THE BALL SEATING PROPERLY. A VACUUM IS CREATED WHICH CAN POTENTIALLY PREVENT THE BALL FROM COMPLETELY SEALING THE VALVE. IF THERE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088484 ↗
• MalfunctionNov 7, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THANK SO MUCH FOR TAKING THE TIME TO TALK TO ME TODAY. AS PER OUR CONVERSATION: YOU HAVE A GENERALIZED COMPLAINT OF AIR-IN-LINE WITH THE IV SET 11522558 WHICH IS THE BD BALL/VALVE SET . THERE HAVE BEEN MULTIPLE INTERNAL REPORTS (UNKNOWN NUMBER OF EVENTS) OF THE BALL FAILING TO SEAT PROPERLY AND AIR GETTING DOWN INTO THE LINE. THERE IS NOT A LOT NUMBER AVAILABLE FOR THESE EVENTS AND THERE WAS NO PATIENT HARM RELATED TO THE AIR IN LINE. AN UNKNOWN NUMBER OF THESE EVENTS HAVE HAPPENED IN AN OUTPATIENT INFUSION CENTER. PLEASE CONFIRM THAT THIS INFORMATION REGARDING THE REPORTED ISSUE OF AIR IN LINE FROM BALL VALVE NOT SEATING PROPERLY IS ACCURATE AND THAT THERE IS NOT ANY OTHER INFORMATION AVAILABLE. ON PREVIOUS SITE VISITS, CPC DETERMINED THAT THE PRACTICE IN THE INFUSION CENTER OF OVER PROGRAMMING THE VTBI (VOLUME TO BE INFUSED) TO INCLUDE THE FLUSH WAS A CONTRIBUTING FACTOR TO THE FAILURE OF THE BALL SEATING PROPERLY. A VACUUM IS CREATED WHICH CAN POTENTIALLY PREVENT THE BALL FROM COMPLETELY SEALING THE VALVE. IF THERE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088482 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED PRIMARY IV TUBING BROKE WHILE CONNECTED TO THE PATIENT. THE TIP OF THE TUBING SOMEHOW CRACKED AND THE TIP WAS LODGED IN THE MICROCLAVE CAP IN THE PATIENT'S PICC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358136 ↗
• MalfunctionMay 30, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AIR GETTING PAST THE BALL IN VALVE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027991 ↗
• MalfunctionMay 12, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BALL VALVE IN DRIP CHAMBER DID NOT APPEAR TO WORK PROPERLY. ADDITIONAL INFORMATION: DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE REPORTED FAILURE? NO. WAS ANY MEDICATION USED WITH THE PRODUCT? IF YES, WHAT WAS THE MEDICATION? REMICADE .(INFLIXIMAB): COULD YOU DESCRIBE IN A LITTLE MORE DETAIL WHAT EXACTLY WAS WRONG WITH THE BALL VALVE? THE PUMP WAS ABLE TO PULL AIR PAST THE BALL IN THE TUBING. THE PUMP ALARMED WHEN THE AIR HIT THE PUMP. AIR HAD TO BE PULLED OUT VIA SYRINGE SO THE REMAINING MEDICATION COULD BE FLUSHED THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925113 ↗
• MalfunctionApr 5, 2023Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED COMPONENT SEPARATION AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: PATIENT ROLLED OVER ONTO THE TUBING AND TUBING AUTOMATICALLY DISCONNECTED AT THE Y-SITE, CHEMO WAS STOPPED. CHEMO SPILL AND PATIENT HAD A LINE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687043 ↗
• MalfunctionFeb 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING BROKE BELOW THE BLUE AND WHITE CASSETTE WHEN REMOVING IT FROM THE PACKAGING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A BD ALARIS PUMP INFUSION SET BALL VALVE BACK CHECK VALVE WAS TAKEN OUT OF PACKAGE DURING MED INFUSION PREP. RN ASSESSED THE TUBING AND THE CONNECTION BROKE BELOW THE BLUE AND WHITE CASSETTE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280711 ↗
• MalfunctionFeb 1, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING BROKE OFF BELOW THE CASSETTE AFTER INFUSING REMICADE AND LEAKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD ALARIS BALL VALVE PUMP INFUSION SET WAS USED FOR MEDICATION INFUSION (REMICADE). AT THE END OF THE INFUSION WHEN ATTEMPTING TO REMOVE THE TUBING FROM THE PUMP FOR DISPOSAL, THE TUBING BROKE OFF BELOW CASSETTE... THERE HAVE BEEN FOUR EVENTS IN THE PAST WEEK WHERE THE TUBING BECOMES DISCONNECTED FROM THE CASSETTE. IN TWO CASES THE MEDICATION LEAKED THROUGH AND HAD TO BE REORDERED AND A SECOND DOSE PREPARED BY PHARMACY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280709 ↗
• MalfunctionJan 31, 2023Disconnection; Leak/Splash; Disconnection; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET DISCONNECTION AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF HAVE REPORTED EVENT OF DISCONNECTION WHERE THE TUBING BECOMES DISCONNECTED FROM THE CASSETTE. IT WAS REPORTED BY THE CUSTOMER THAT THEY WERE PRIMING IV FLUIDS AND THE TUBING DISCONNECTED. NONE OF THESE EVENTS INVOLVED HAZARDOUS DRUGS SO DID NOT REQUIRE HAZARDOUS DRUG SPILL CLEANUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273449 ↗
• MalfunctionJan 23, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING DISCONNECTED FROM BENEATH THE CASSETTE DURING THE PRIMING PROCESS AND LEAKED REMICADE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING PRIMING OF INFUSION SET FOR REMICADE MEDICATION ADMINISTRATION THE BD ALARIS BALL VALVE TUBING DISCONNECTED UNDERNEATH THE CASSETTE... THERE HAVE BEEN FOUR EVENTS IN THE PAST WEEK WHERE THE TUBING BECOMES DISCONNECTED FROM THE CASSETTE. IN TWO CASES THE MEDICATION LEAKED THROUGH AND HAD TO BE REORDERED AND A SECOND DOSE PREPARED BY PHARMACY. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231050 ↗
• MalfunctionJan 23, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING DISCONNECTED DURING USE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF HAVE REPORTED EVENTS OF DISCONNECTION WITH THE BD ALARIS PUMP MODULE SET BALL VALVE TUBING BD 11522558. THERE HAVE BEEN FOUR EVENTS IN THE PAST WEEK WHERE THE TUBING BECOMES DISCONNECTED FROM THE CASSETTE. REACHING OUT WITH A PRODUCT CONCERN. STAFF HAVE REPORTED EVENTS OF DISCONNECTION WITH THE BD ALARIS PUMP MODULE SET BALL VALVE TUBING, BD 11522558. THERE HAVE BEEN FOUR EVENTS IN THE PAST WEEK WHERE THE TUBING BECOMES DISCONNECTED FROM THE CASSETTE. IN TWO CASES THE MEDICATION LEAKED THROUGH AND HAD TO BE REORDERED AND A SECOND DOSE PREPARED BY PHARMACY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231049 ↗
• MalfunctionJan 13, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING A BD ALARIS¿ LVP 20D 3SS CV BV LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I PLACED THE DRUG ON THE IV POLE AND THE SPIKE ON THE PRIMARY TUBING THAT GOES INTO THE DRUG FELL OUT SPONTANEOUSLY AND LEAKED A SIGNIFICANT AMOUNT OF DRUG ONTO MYSELF, THE PUMP, AND THE FLOOR. I CLEANED THE AREA AND HAD PHARMACY MAKE ANOTHER BAG FOR THE PATIENT TO RECEIVE AND DISPOSED OF THE ONE THAT LEAKED.

  Patient problems: Chemical Exposure

  MAUDE report 16160928 ↗
• MalfunctionJan 12, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE INFUSION SET THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ALL SEEM TO BE COMING APART SOMEWHERE IN THE SET. IT SEEMS LIKE THE GLUE IS NOT WORKING ON OUR SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16152947 ↗
• MalfunctionJan 11, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING SEPARATED FROM THE SAFETY CLAMP SITE WHILE BEING INSERTED INTO THE PUMP, LEAKING SALINE ONTO THE GROUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD ALARIS PUMP INFUSION SET TUBING DEFECTIVE. THE TUBING BECAME DISCONNECTED AT THE SAFETY CLAMP SITE. TUBING WAS PRIMED. AS RN WAS INSERTING THE TUBING INTO THE PUMP, THE TUBING BROKE OFF AT THE SAFETY CLAMP SITE AND NORMAL SALINE WAS FREELY FLOWING FROM THE TUBING ONTO THE GROUND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16140840 ↗
• MalfunctionJan 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING A BD ALARIS PUMP MODULE SMARTSITE INFUSION SET THERE WAS COMPONENT SEPARATION. THIS OCCURRED 45 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITS DETACHING/COMING LOOSE IN PLACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134049 ↗
• MalfunctionJan 10, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING A BD ALARIS PUMP MODULE SMARTSITE INFUSION SET THERE WAS COMPONENT SEPARATION. THIS OCCURRED 45 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITS DETACHING/COMING LOOSE IN PLACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134012 ↗