Alaris 2202-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI 10885403274039), received between Dec 7, 2018 and May 27, 2026 — classified as 2 injuries, 246 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (139 reports).

3 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 19, 2026Open, 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 · FDA record ↗

2. Jul 8, 2025Open, 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-2180-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. Oct 11, 2023Open, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0349-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 248 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN I GOT ON SHIFT AND WAS GETTING REPORT THE IV RUNNING D 10 SPN WITH HEPARIN ALARMED FOR AIR IN THE LINE. WE DIDN'T SEE ANY AIR AND RAN THE LINE AGAIN. A FEW MINUTES LATER I NOTICED A 1.5-2 CM AIR BUBBLE IN THE LINE. I RAN THE LINE TO GET RID OF THE BUBBLE BUT IT GOT CAUGHT IN THE FILTER. I HAD THE CHARGE NURSE HELP ME TO CLEAR THE FILTER AND WE DID BUT AS WE WERE ALLOWING THE END OF THE IV CONNECTER FILL UP TO RE ATTACH THE FLUIDS TO THE BABY WE NOTICED IT WAS QUICKLY BACK FLOWING INTO THE FILTER CHAMBER. WE DECIDED IT WAS BAD TUBING AND GOT NEW. WE PRIMED THE LINE AND MADE SURE THERE WAS NO AIR IN THE FILTER AND CONNECTED TO THE BABY. 10 OR SO MINUTES LATER I WAS INSPECTING IT AGAIN AND NOTICED A LARGE AMOUNT OF AIR IN THE FILTER THAT HAD RECENTLY BEEN FULL OF FLUID. WE RAN FLUIDS THROUGH IT AGAIN AND IT LOOKED FULL OF FLUID. EVERYTHING LOOKED GOOD SO WE REATTACHED THE FLUIDS TO THE BABY. WHILE FEEDING THE BABY 20 OR SO MINUTES LATER A 1 CM AIR BUBBLE SHOWED UP BETWEEN THE BABY AND THE FILTER. WE LOOKED AT THE LOT NUMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25307145 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT IV PUMP BEEPING "AIR IN LINE." THE NURSE REMOVED THE TUBING FROM THE CHANNEL IN AN ATTEMPT TO FIX IT AND NOTICED THAT THE IV FLUID WAS LEAKING FROM THE TUBING (TOP WHERE THE RUBBER INSERT MEETS THE BLUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492010 ↗
• MalfunctionJul 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT TUBING LEAKING, UNABLE TO IDENTIFY SOURCE OF LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22536669 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUNCTURE IN "PUMP SEGMENT" AREA AT TPN ¿ FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523206 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED, THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT "TREND OF A SPECIFIC BREAKAGE POINT ON SOME TUBING SETS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436907 ↗
• MalfunctionJun 13, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THERE WAS DEBRIS NOTED IN THE DRIP CHAMBER OF SET AND SET WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203644 ↗
• MalfunctionMar 19, 2025Leak/Splash; Leak/Splash

  SAMPLE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649324 ↗
• MalfunctionMar 17, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM, VERBATIM: HOPE YOU'RE DOING WELL. WE ARE SEEING A TREND IN LIPID LINE OCCLUSIONS INVOLVING FAILURE TO PRIME. STAFF ARE HAVING TO GO THROUGH MULTIPLE SETS AND IN SOME CASES OBTAIN ADDITIONAL LIPIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617339 ↗
• MalfunctionMar 17, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM VERBATIM: WE ARE SEEING A TREND IN LIPID LINE OCCLUSIONS INVOLVING FAILURE TO PRIME. STAFF ARE HAVING TO GO THROUGH MULTIPLE SETS AND IN SOME CASES OBTAIN ADDITIONAL LIPIDS. I HAVE ONE LOT NUMBER TO SHARE BUT NOT KNOWN TO BE LIMITED TO THAT LOT NUMBER. PEASE LET ME KNOW IF THIS IS A TREND BD IS AWARE OF AND ANY PRODUCT ISSUES WITH THIS TUBING. APPRECIATE YOUR FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617330 ↗
• MalfunctionFeb 11, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356769 ↗
• MalfunctionFeb 7, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING . IT WAS REPORTED BY CUSTOMER THAT PUMP ALARMING "PATIENT SIDE OCCLUSION", IV PATENCY VERIFIED. CHANGED OUT PUMP W/ SAME RESULT. CHANGED OUT TUBING AND PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335025 ↗
• MalfunctionJan 7, 2025Complete Blockage; Defective Device; Complete Blockage; Defective Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THEY HAD LIPID TUBING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092509 ↗
• MalfunctionJan 7, 2025Complete Blockage; Complete Blockage

  MATERIAL # 2202-0007 AND BATCH # 24066673, 24055585. IT WAS REPORTED BY CUSTOMER THAT THEY HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE THEY HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE, AND THEY ALSO HAD OCCLUSION ISSUES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. FIRST INCIDENT EMAIL DATED: 24NOV2024. I JUST WANTED TO MAKE MATERIALS AWARE OF ISSUES WE HAVE BEEN HAVING WITH BD ALARIS PUMP INFUSION SET WITH 1.2 MICRON FILTER (WHAT WE USE FOR LIPIDS AND SMOF LIPIDS). THE FIRST 2 ISSUES NOTED (NO IRS DONE) HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE. EVERYTHING WAS TROUBLESHOT BUT WOULD NOT STOP ALARMING HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE. THE FINAL 2 ISSUES THE LIPIDS WERE PRIMED THROUGH THE TUBING AND ATTACHED TO THE ALARIS PUMP. THEY INFUSED FOR A BIT OF TIME THEN STOPPED INFUSING, WHEN THEY TROUBLESHOT THE ISSUE, THEY FOUND THAT THE LIPIDS WOULD NOT MOVE IN THE TUBING AT ALL. EVEN IF WE SQUEEZED THE BAG OF LIPIDS WITH THE TUBING SET WIDE OPEN IT WOULD NOT MOVE AT ALL. I WAS ABLE TO GET THE LOT NUMBER OF ONE OF THE INFUSION SETS (LOT # (10) 24066673). I JUST WANTED EVERYONE AWARE SO THAT IF OTHERS IN HOSPITAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092505 ↗
• MalfunctionJan 7, 2025Complete Blockage; Complete Blockage

  MATERIAL#: 2202-0007, BATCH#: 24066673, 24055585. IT WAS REPORTED BY CUSTOMER THAT THEY HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE THEY HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE, AND THEY ALSO HAD OCCLUSION ISSUES. RCC RECEIVED A COMPLAINT VIA EMAIL. FIRST INCIDENT EMAIL DATED: ON (B)(6) 2024. I JUST WANTED TO MAKE MATERIALS AWARE OF ISSUES WE HAVE BEEN HAVING WITH BD ALARIS PUMP INFUSION SET WITH 1.2 MICRON FILTER (WHAT WE USE FOR LIPIDS AND SMOF LIPIDS). THE FIRST 2 ISSUES NOTED (NO IRS DONE) HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE. EVERYTHING WAS TROUBLESHOT BUT WOULD NOT STOP ALARMING HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE. THE FINAL 2 ISSUES THE LIPIDS WERE PRIMED THROUGH THE TUBING AND ATTACHED TO THE ALARIS PUMP. THEY INFUSED FOR A BIT OF TIME THEN STOPPED INFUSING, WHEN THEY TROUBLESHOT THE ISSUE, THEY FOUND THAT THE LIPIDS WOULD NOT MOVE IN THE TUBING AT ALL. EVEN IF WE SQUEEZED THE BAG OF LIPIDS WITH THE TUBING SET WIDE OPEN IT WOULD NOT MOVE AT ALL. I WAS ABLE TO GET THE LOT NUMBER OF ONE OF THE INFUSION SETS (LOT#: (10) 24066673). I JUST WANTED EVERYONE AWARE SO THAT IF OTHERS IN HOSPITAL ARE HAVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092504 ↗
• MalfunctionJan 6, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY HAD LIPID TUBING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21087242 ↗
• MalfunctionJan 3, 2025Complete Blockage; Complete Blockage

  MATERIAL#: 2202-0007, BATCH#: 24066673, 24055585. IT WAS REPORTED BY CUSTOMER THAT THEY HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE THEY HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE, AND THEY ALSO HAD OCCLUSION ISSUES. RCC RECEIVED A COMPLAINT VIA EMAIL. FIRST INCIDENT EMAIL DATED: ON (B)(6) 2024. I JUST WANTED TO MAKE MATERIALS AWARE OF ISSUES WE HAVE BEEN HAVING WITH BD ALARIS PUMP INFUSION SET WITH 1.2 MICRON FILTER (WHAT WE USE FOR LIPIDS AND SMOF LIPIDS). THE FIRST 2 ISSUES NOTED (NO IRS DONE) HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE. EVERYTHING WAS TROUBLESHOT BUT WOULD NOT STOP ALARMING HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE. THE FINAL 2 ISSUES THE LIPIDS WERE PRIMED THROUGH THE TUBING AND ATTACHED TO THE ALARIS PUMP. THEY INFUSED FOR A BIT OF TIME THEN STOPPED INFUSING, WHEN THEY TROUBLESHOT THE ISSUE, THEY FOUND THAT THE LIPIDS WOULD NOT MOVE IN THE TUBING AT ALL. EVEN IF WE SQUEEZED THE BAG OF LIPIDS WITH THE TUBING SET WIDE OPEN IT WOULD NOT MOVE AT ALL. I WAS ABLE TO GET THE LOT NUMBER OF ONE OF THE INFUSION SETS (LOT#: (10) 24066673). I JUST WANTED EVERYONE AWARE SO THAT IF OTHERS IN HOSPITAL ARE HAVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068802 ↗
• MalfunctionJan 3, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE THEY HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE, AND THEY ALSO HAD OCCLUSION ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067802 ↗
• MalfunctionJan 3, 2025Complete Blockage; Complete Blockage

  MATERIAL # 2202-0007 BATCH # 24066673, 24055585. IT WAS REPORTED BY CUSTOMER THAT THEY HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE THEY HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE, AND THEY ALSO HAD OCCLUSION ISSUES. RCC RECEIVED A COMPLAINT VIA EMAIL. FIRST INCIDENT EMAIL DATED: ON (B)(6) 2024. I JUST WANTED TO MAKE MATERIALS AWARE OF ISSUES WE HAVE BEEN HAVING WITH BD ALARIS PUMP INFUSION SET WITH 1.2 MICRON FILTER (WHAT WE USE FOR LIPIDS AND SMOF LIPIDS). THE FIRST 2 ISSUES NOTED (NO IRS DONE) HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE. EVERYTHING WAS TROUBLESHOT BUT WOULD NOT STOP ALARMING HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE. THE FINAL 2 ISSUES THE LIPIDS WERE PRIMED THROUGH THE TUBING AND ATTACHED TO THE ALARIS PUMP. THEY INFUSED FOR A BIT OF TIME THEN STOPPED INFUSING, WHEN THEY TROUBLESHOT THE ISSUE, THEY FOUND THAT THE LIPIDS WOULD NOT MOVE IN THE TUBING AT ALL. EVEN IF WE SQUEEZED THE BAG OF LIPIDS WITH THE TUBING SET WIDE OPEN IT WOULD NOT MOVE AT ALL. I WAS ABLE TO GET THE LOT NUMBER OF ONE OF THE INFUSION SETS (LOT # (10) 24066673). I JUST WANTED EVERYONE AWARE SO THAT IF OTHERS IN HOSPITAL ARE HAVIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067801 ↗
• MalfunctionJan 3, 2025Complete Blockage; Complete Blockage

  MATERIAL # 2202-0007 BATCH # 24066673, 24055585 IT WAS REPORTED BY CUSTOMER THAT THEY HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE THEY HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE, AND THEY ALSO HAD OCCLUSION ISSUES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. FIRST INCIDENT EMAIL DATED: 24NOV2024 I JUST WANTED TO MAKE MATERIALS AWARE OF ISSUES WE HAVE BEEN HAVING WITH BD ALARIS PUMP INFUSION SET WITH 1.2 MICRON FILTER (WHAT WE USE FOR LIPIDS AND SMOF LIPIDS). THE FIRST 2 ISSUES NOTED (NO IRS DONE) HAD THE ALARIS PUMP ALARMING WITH HIGH PRESSURE. EVERYTHING WAS TROUBLESHOT BUT WOULD NOT STOP ALARMING HAD TO CHANGE OUT THE TUBING TO A NEW SET AND IT INFUSED WITHOUT ISSUE. THE FINAL 2 ISSUES THE LIPIDS WERE PRIMED THROUGH THE TUBING AND ATTACHED TO THE ALARIS PUMP. THEY INFUSED FOR A BIT OF TIME THEN STOPPED INFUSING, WHEN THEY TROUBLESHOT THE ISSUE THEY FOUND THAT THE LIPIDS WOULD NOT MOVE IN THE TUBING AT ALL. EVEN IF WE SQUEEZED THE BAG OF LIPIDS WITH THE TUBING SET WIDE OPEN IT WOULD NOT MOVE AT ALL. I WAS ABLE TO GET THE LOT NUMBER OF ONE OF THE INFUSION SETS (LOT # (10) 24066673). I JUST WANTED EVERYONE AWARE SO THAT IF OTHERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067798 ↗
• MalfunctionDec 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL # 2202-0007. BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY DID NOT SEE THIS BLOOD COMING BACK INTO THE TUBING. VERBATIM: ISSUE: WHEN RNS DID BEDSIDE REPORT AND TRACED LINES AT ABOUT 0750, THEY NOTICED BLOOD MOVING BACKWARD AND GOING INTO THE TRIFUSE AND A COUPLE INCHES UP THE TPN LINE. THE OFFGOING RN HAD CHECKED THE LINE AT 0600 AND DID NOT SEE THIS BLOOD COMING BACK INTO THE TUBING. ONCOMING RN REPOSITIONED THE LINE TO PUT THE FILTER ABOVE THE BABY'S LEVEL RATHER THAN BELOW TO TRY TO GET THE FLOW TO NORMALIZE. RN LEFT BEDSIDE TO ALLOW GRAVITY TO ASSIST BLOOD TO FLOW BACK INTO BABY. AFTER APPROX 30-40 MINS, RN RETURNED AND ONLY MARGINAL PROGRESS HAD BEEN MADE. RN THEN FLUSHED THE LINE TO CLEAR IT, POSITIONED THE FILTER ABOVE THE BABY AGAIN, AND ATTEMPTED TO ALLOW BLOOD REMAINING IN TPN TO FLOW BACK INTO BABY. RN MONITORED THE LINE AND RATHER THAN THE BLOOD RETURNING TO THE BABY, THE BLOOD AND SOME SMOF CONTINUED TO SLOWLY BACK UP INTO THE TPN LINE. RN THOROUGHLY INSPECTED THE FULL LINE AND NOTED THE FILTER WAS NEARLY HALFWAY FULL OF AIR, THE VENT PORT WAS NOT OPEN, AND THE CHAMBER FOR THE TPN WAS FILLED TO THE BRIM, MAKING IT IMPOSSIBLE TO ENSURE THE BAG WAS DRIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892325 ↗
• MalfunctionApr 26, 2024Material Separation; Material Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197533 ↗
• MalfunctionApr 26, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 2202-0007, BATCH #: UNKNOWN. TWO EVENTS WERE REPORTED BY CUSTOMER THAT TUBING DISCONNECTED FROM CVL AND THE OTHER WAS A LEAK FROM A PINHOLE IN THE STRETCHY PORTION OF THE TUBING IN THE PUMP CHAMBER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I WANTED TO FOLLOW UP AFTER THE HUDDLE DISCUSSIONS RE: TPN TUBING ISSUES. FOR 2WEST, THE 2 INCIDENTS INVOLVING TPN TUBING ARE COMPLETELY DIFFERENT ISSUES (TUBING DISCONNECTED FROM CVL AND THE OTHER WAS A LEAK FROM A PINHOLE IN THE STRETCHY PORTION OF THE TUBING IN THE PUMP CHAMBER), BUT BOTH HAPPENED TO OCCUR ON THE SAME PATIENT. I UNDERSTAND THAT 4EAST ALSO EXPERIENCED A LEAK IN THE TUBING SIMILAR TO THE ONE ON 2WEST. I WOULD LEAVE THE DECISION ABOUT ENGAGING THE REP TO COME ONSITE TO ALL OF YOU FROM AN OVERALL PATIENT SAFETY PERSPECTIVE. I AM NOT AWARE OF THE HOUSE WIDE ISSUES WITH THIS TUBING, AND FEEL STRONGLY THAT OUR 2 INCIDENTS ON 2WEST ARE UNRELATED. GOOD MORNING, (B)(6), SEEMS WE ARE HAVING A FEW REPORTED PRODUCT ISSUES WITH REF#(B)(4). I HAVE THE PRODUCT THAT FAILED BUT UNFORTUNATELY DO NOT HAVE PACKAGING OR LOT #S TO PROVIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197080 ↗
• MalfunctionApr 18, 2024Air/Gas in Device; Air/Gas in Device

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134751 ↗
• MalfunctionApr 18, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134748 ↗
• MalfunctionMar 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CALLER DESCRIBING USING OF INFUSION SET 2202-0007. CALLER STATES THIS SET WAS USED IN THE NICU FOR THE ADMINISTRATION OF TPN. CALLER STATES THE ROLLER CLAMP WAS ROLLED DOWN AS FAR AS POSSIBLE AFTER PRIMING THE SET WITH SOLUTION. CALLER STATES THE SOLUTION CAME OUT OF THE PRIMED TUBING SET EVEN WITH THE ROLLER CLAMP SECURED. CALLER STATES THE PINCH CLAMP HAD TO BE USED TO KEEP ANYMORE SOLUTION FROM LEAKING OUT OF THE TUBING SET. CALLER STATES THIS HAPPENED WITH THREE TUBING SETS. IS THIS HOW THE TUBING SET IS SUPPOSED TO FUNCTION?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891826 ↗