Alaris, SmartSite 20038ERecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 07613203011976), received between Sep 28, 2018 and May 20, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Crack” (10 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Backflow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT WET SPOT FOUND ON THE PATIENTS PAD AND BLOOD BACKED UP INTO THE CENTRAL LINE TUBING AND TUBING WAS LEAKING MEDICATION DIRECTLY ABOVE THE CONNECTION TO THE CENTRAL LINE WHERE ALL 3 MEDICATIONS MEET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234397 ↗
• MalfunctionMay 20, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WET SPOT FOUND ON THE PATIENTS PAD AND BLOOD BACKED UP INTO THE CENTRAL LINE TUBING AND TUBING WAS LEAKING MEDICATION DIRECTLY ABOVE THE CONNECTION TO THE CENTRAL LINE WHERE ALL 3 MEDICATIONS MEET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233907 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY CUSTOMER HAS BEEN HAVING ISSUES WITH BIFUSE & TRIFUSE EXTENSION SETS. THEY ARE EXPERIENCING THAT THE DEVICE IS BREAKING WHEN IT IS CONNECTED/DISCONNECTED FROM THE IV TUBING. ADDITIONALLY, THE BLUE SEAL IS DROPPING AND REMAINS STUCK IN THE DOWN POSITION. THEY DO NOT HAVE LOT NUMBERS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2026 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM. PRODUCT WAS BROKEN AND NEEDED NEW PRODUCT. SLOWED THROUGHPUT IN THE UNIT. THEY ARE EXPERIENCING THAT THE DEVICE IS BREAKING WHEN IT IS CONNECTED/DISCONNECTED FROM THE IV TUBING. ADDITIONALLY, THE BLUE SEAL IS DROPPING AND REMAINS STUCK IN THE DOWN POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021850 ↗
• MalfunctionDec 23, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS PREPARING TO USE 3 PORT EXTENSION SET #20038E, NOTED ONE OF THE PORTS WAS UNABLE TO FLUSH LOT # (10) 24115172. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880020 ↗
• MalfunctionDec 4, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE TURNING THE PATIENT, THERE WAS A SIGNIFICANT DROP IN THE PATIENT'S BLOOD PRESSURE. THIS REQUIRED EMERGENT ACTIONS, AND THE PHYSICIANS WERE NOTIFIED AND BROUGHT TO BEDSIDE. MEDICATIONS WERE ADMINISTERED AND WERE TITRATED TO INCREASE THE PATIENT'S BLOOD PRESSURE. WHILE PLACING A BACKBOARD UNDERNEATH THE PATIENT, BLOOD WAS DISCOVERED UNDER THE PATIENT'S BACK. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE IV TUBING CONNECTED TO THE PATIENT'S RIJ [RIGHT INTERNAL JUGULAR] CORDIS WAS SEVERED. THE MEDICATIONS THE PATIENT WAS RECEIVING TO MAINTAIN THEIR BLOOD PRESSURE WERE ADMINISTERED THROUGH THIS LINE. DUE TO THE DISCONNECTION, THE PATIENT WAS NOT RECEIVING THE MEDICATIONS AND EXPERIENCED BLOOD LOSS FROM THE SEVERED LINE AS WELL. THE SEVERED IV TUBING WAS PROMPTLY REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716511 ↗
• MalfunctionNov 6, 2025Disconnection; No Flow

  WHILE TURNING THE PATIENT, THERE WAS A SIGNIFICANT DROP IN THE PATIENT'S BLOOD PRESSURE. THIS REQUIRED EMERGENT ACTIONS, AND THE PHYSICIANS WERE NOTIFIED AND BROUGHT TO BEDSIDE. MEDICATIONS WERE ADMINISTERED AND WERE TITRATED TO INCREASE THE PATIENT'S BLOOD PRESSURE. WHILE PLACING A BACKBOARD UNDERNEATH THE PATIENT, BLOOD WAS DISCOVERED UNDER THE PATIENT'S BACK. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE IV TUBING CONNECTED TO THE PATIENT'S RIJ [RIGHT INTERNAL JUGULAR] CORDIS WAS SEVERED. THE MEDICATIONS THE PATIENT WAS RECEIVING TO MAINTAIN THEIR BLOOD PRESSURE WERE ADMINISTERED THROUGH THIS LINE. DUE TO THE DISCONNECTION, THE PATIENT WAS NOT RECEIVING THE MEDICATIONS AND EXPERIENCED BLOOD LOSS FROM THE SEVERED LINE AS WELL. THE SEVERED IV TUBING WAS PROMPTLY REPLACED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 23485235 ↗
• MalfunctionAug 14, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONNECTOR WAS HOOKED UP TO PERIPHERAL IV ON BABY IN OUR NICU, THE IV TAKEN OUT AND REPLACED AND WHILE REATTACHING CONNECTOR IT CRACKED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812236 ↗
• MalfunctionAug 14, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTOR USED IN THE NICU AND CCU FOR IV TUBING BD SMART SITE EXTENSION SET, LOT # (10) 24066937 CRACKED WHILE IN USE ON THE INFANT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE IMPACT TO THE PATIENT? NO. DID THE REPORTED ISSUE RESULT IN ANY LEAKS? YES. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? D10. WAS THIS A CHEMOTHERAPY DRUG? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811872 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. ONE OF MY STAFF NURSES WAS UTILIZING THE BD SMARTSITE 3 NEEDLE FREE VALVE EXTENSION SET (REF20038E). ONCE SHE PRIMED HER FLUIDS THROUGH THE EXTENSION SET AND TRIED TO CONNECT THE EXTENSION SET TO HER CENTRAL LINE, THE PRODUCT SNAPPED RIGHT AT THE CONNECTOR. THIS BROKE STERILITY AND REQUIRED THE RN TO RE-PRIME ALL OF HER IV FLUIDS UNDER STERILE CONDITIONS. THE PATIENT DID NOT RESPOND WELL TO BEING OFF IV PRESSORS FOR BLOOD PRESSURE DUE TO THIS DELAY.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21617512 ↗
• MalfunctionApr 26, 2024Defective Component; Defective Component

  MATERIAL # 20038E BATCH # UNKNOWN IT WAS REPORTED BY CUSTOMER THAT NOTED 3-WAY PORT CRACKED/BROKEN AT MALE END SIDE : RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAVE 1 EACH POTENTIALLY DEFECTIVE TRI PORT EXTENSION SET 20038E. LOT NUMBER WAS NOT DOCUMENTED. 1. WHAT WAS THE DATE AND TIME OF THE EVENT(S)? 3/26/2024 TIME UNKNOWN 2. PLEASE CONFIRM THE TUBING MODEL/REF NUMBER? 20038E 3. HOW MANY TUBINGS ARE YOU SENDING IN TO US FOR INVESTIGATION? 1 4. WHEN IS THE DISLODGE/SEPARATION BEING NOTICED? UNKNOWN 5. DURING PRIMING? NO 6. DIRECTLY OUT OF THE PACKAGING? NO 7. AFTER BEING CONNECTED TO A PATIENT? 24 HOURS? 48 HOURS OR 72 HOURS? UNKNOWN 8. WHAT WAS INFUSING AT THE TIME OF THE EVENT? UNKNOWN 9. WAS THE TUBING CONNECTED TO A PATIENT? YES 10. WAS THERE ANY PATIENT HARM? NO 11. DID THE PATIENT REQUIRE MEDICAL INTERVENTION BECAUSE OF THE EVENT? NO 12. HOW DID THIS OCCUR? NOTED 3-WAY PORT CRACKED/BROKEN AT MALE END SIDE THAT TWISTS, NO FLUID LEAKING NOTED. 3-WAY PORT STILL SECURED/CONNECTED TO SMART SITE AT THE TIME. 13. WHAT WAS INFUSING AT THE TIME OF THE EVENT? UNKNOWN 14. PLEASE CLARIFY: DID A SECONDARY INFUSION FLOW INTO THE PRIMARY DRIP CHAMBER? UNKNOWN 15. LOT # UNKNOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19198284 ↗
• MalfunctionAug 11, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WAS BLOCKED DURING THE FLUSH AND WHEN TRYING TO DELIVER PITOCIN DURING THE INFUSION. THIS OCCURRED IN AN UNSPECIFIED LOT WITH 3 - 5 SETS, AND ONE SET FROM LOT 23055439. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE FOUND THAT WHEN I GO TO FLUSH THE 3 PRONG IV ATTACHMENT, 1 OF THE PORTS SOMETIMES DO NOT FLUSH AT ALL NO MATTER HOW MUCH FORCE USED (AND I'M REFERRING TO STRAIGHT OUT OF THE PACKAGE BEFORE IT IS EVER CONNECTED TO THE PATIENT). . TONIGHT ONE OF THE NURSES CAME OUT HER ROOMS AFTER DELIVERY ASKING FOR HELP BECAUSE HER PITOCIN WAS NOT RUNNING INTO THE PATIENT AT ALL AFTER DELIVERY. I TRIED FLUSHING THE LINE FOR HER AND WAS MET WITH A LOT OF RESISTANCE AND WAS UNABLE TO FLUSH. I THEN TRIED REMOVING THE PITOCIN FROM ONE OF THE 3 PRONGS WHICH IT WAS ON AND WAS UNABLE TO FLUSH FROM FURTHER DOWN AS WELL. IT THEN "CLICKED" THAT MAYBE THIS WAS ONE OF THE DEFECTIVE 3 PRONG IV CONNECTORS, SO I SWITCHED THE IV LINE TO THE MAIN PORT AND THE FLUIDS RAN NICELY... ADDITIONAL INFO FROM CUSTOMER: (07-AUG-2023) IS THERE ANY ADVERSE EVENT OCCURRED? NO WHAT IS THE TOTAL NUMBER OF OCCURRENCES? 3-5 APPROXIMATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17507455 ↗
• MalfunctionMar 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: JUST WANTED TO PASS THIS ALONG AS THIS IS THE FIRST I AM HAVING AN ISSUE WITH RECENTLY O#: 23331 INCIDENT: (B)(4): TOLD WE HAD AN ISSE WITH 3 TRIFUSES. TWO OF THE LUMENS WOULD FLUSH, BU THE 3RD WOULD NOT FLUSH AND WAS NOT ALLOWING FLOW WHEN FLUSHING. BELOW IS THE REF#: ADDITIONAL INFORMATION RECEIVED: SPOKE WITH CUSTOMER AND SHE CONFIRMED THAT THERE WAS ONLY ONE OCCURRENCE AND THE REFERENCE OF "3 TRIFUSES" REFERS TO THE NAME THE PRODUCT IS REFERRED TO WITHIN THE ORGANIZATION AND NOT THE NUMBER OF OCCURRENCES. NO SAMPLE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531506 ↗
• MalfunctionMar 9, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 OF THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET CLOGGED WOULD NOT FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TOLD WE HAD AN ISSUE WITH 3 TRIFUSES. TWO OF THE LUMENS WOULD FLUSH, BUT THE 3RD WOULD NOT FLUSH AND WAS NOT ALLOWING FLOW WHEN FLUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519306 ↗
• MalfunctionFeb 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ACTUALLY JUST RECEIVED A REPLACEMENT SHIPMENT THAT WERE ALSO DISCOLORED. NO ADVERSE EVENTS, NO PATIENT IMPACT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301182 ↗
• MalfunctionJan 24, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE TRI-PORTS ON THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WERE DISCOLORED WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS AN ENTIRE LOT NUMBER OF DISCOLORED TRIFURCATES WHICH IS LEADING US TO DOUBT THE INTEGRITY OF THE PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238312 ↗
• MalfunctionJun 13, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET EXPERIENCED AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ENCOUNTERING AIR BACKING UP IN LINES DURING PRE-PRIMING/PRE RUNNING OF INFUSION LINES IN PREPARATION FOR UNINTERRUPTED LINE CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14673754 ↗
• MalfunctionApr 21, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT SEEMS THAT ONLY 2 OF THE 3 CLAVES WORK PROPERLY. I HAVE HAD MULTIPLE REPORTS THAT WHEN HOOKED UP TO THE PUMP IT READS OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166726 ↗
• MalfunctionFeb 7, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 10 BD ALARIS SMARTSITE EXTENSION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID WILL FLOW THROUGH THE TUBING. THE USER EVEN USED A SYRINGE TO PRIME THE TUBING WITH A LOT OF PRESSURE, BUT THE FLUID WOULD NOT GO THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13473214 ↗
• MalfunctionMar 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A TRI-PORT EXT W/3 VLV PORTS HAD FOREIGN MATTER AT AN UNSPECIFIED TIME. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SMART SITE CONNECTOR IS YELLOW TINTED. VERBATIM: YELLOW PORTION OF SMARTSITE CONNECTOR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11418414 ↗
• MalfunctionSep 15, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE TRI-PORT EXT W/3 VLV PORTS EXPERIENCED AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS NOTICED AT THE BEGINNING OF THE SHIFT THAT THE AIR FILTER ON THE TPN TUBING HAD DE-PRIMED (PRODUCT REFERENCE NUMBER 2432-0007). THE LINE WAS DISCONNECTED FROM THE ECMO MANIFOLD AND DE-AIRED BY A LINE TEAM MEMBER ASSIGNED TO A PATIENT IN THE POD. THIS OCCURRED TWICE. SHORTLY AFTER 2000 MICRO-BUBBLES WERE NOTED IN THE DISTAL 3-WAY STOPCOCK LOCATED IN LINE BETWEEN THE MANIFOLD AND THE ECMO PIGTAIL. THE STOPCOCK WAS CHANGED, AIR WAS THEN NOTED IN THE MANIFOLD, IT WAS CHANGED. AT APPROX. 2030 I CAME TO THE BEDSIDE WHERE ALL LINES AND FILTERS WERE RE-EXAMINED. ALL LINES WERE DISCONNECTED INDIVIDUALLY AND DE-AIRED AND REATTACHED, NEW INTRA LIPIDS WERE HUNG WITH NEW AIR FILTER (PRODUCT REFERENCE4 NUMBER 20129E). WITHIN 5 MINUTES THE TPN AIR FILTER HAD FILLED WITH AIR, THE LINE WAS REHUNG WITH A SEPARATE AIR FILTER (PRODUCT REFERENCE NUMBER 10011865) AND REHUNG. SHORTLY AFTER ALL AIR FILTERS IN LINE (# 20129E AND 10011865) HAD FILLED WITH AIR, MICRO-BUBBLES WERE NOTED AGAIN IN THE 3-WAY STOPCOCK. ALL FILTERS WERE REMOVED FROM THE LIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538609 ↗
• MalfunctionSep 14, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT TRI-PORT EXT W/3 VLV PORTS WERE BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: BATCH NO: UNKNOWN. IT WAS REPORTED THAT THERE WAS DIFFICULTY FLUSHING/PRIMING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10531905 ↗
• MalfunctionAug 7, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT TRI-PORT EXT W/3 VLV PORTS WERE BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 20038E BATCH NO: 20025053 AND 20045999 IT WAS REPORTED THE TUBING WOULD NOT FLUSH. WE HAVE HAD A HANDFUL OF REPORTS FROM ICU NURSES THAT THAT AT TIMES ONE OF THE PORTS ON OUR TRI PORT EXTENSIONS SET ARE NOT ABLE TO FLUSH. A NURSE SAVED A COUPLE OF ME THAT THEY FOUND UNABLE TO FLUSH THOUGH. I WAS ABLE TO FLUSH THROUGH THESE DEVICES WITH CONSIDERABLE EFFORT. I WOULD LIKE TO MAIL THESE TWO DEVICES IN TO HAVE THEM ASSESSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382722 ↗
• MalfunctionJul 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TRI-PORT EXT W/3 VLV PORTS CRACKED AND LEAKED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN, BATCH #: UNKNOWN. IT WAS REPORTED NECK THAT SPINS AT THE MALE END OF THE TRIFUSE HAVE CRACKED/LEAKED ABOUT 5 DIFFERENT TIMES. OUR NURSES ARE SEEING MANY OF THE TRIFUSES CRACKING AT THE PART THAT ATTACHES THE TRIFUSE TO THE IV TUBING OR IV HUB. THE PART I AM REFERRING TO IS THE NECK THAT SPINS AT THE MALE END OF THE TRIFUSE. THEY ARE NOTICING LEAKING AND CRACKING AT THIS JUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251974 ↗
• MalfunctionAug 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS LONG STRING LIKE MATERIAL WAS PULLED THROUGH ONE OF THE VALVES. WHEN DRAWING BLOOD FROM THE DEVICE IT WAS NOTED THAT A LONG STRING LIKE MATERIAL WAS PULLED THROUGH ONE OF THE VALVES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8873868 ↗
• InjuryMar 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON 2/17 AT 6:30 PM, TPN, LIPIDS AND NARCAN INFUSIONS WERE INITIATED VIA PUMP MODULE AT AN UNSPECIFIED RATE THROUGH THE TRIFUSE EXTENSION SET. ALSO INFUSING AT THE TIME WAS A MORPHINE PCA SYRINGE 1:1 INFUSION THROUGH A CVL (TRIPLE LUMEN CATHETER). AT 11AM THE FOLLOWING DAY, THE NURSE NOTICED A LEAK AT THE TRIFUSE EXTENSION SET "AT CONNECTION INTO PCA.." THE LINE WAS CHANGED AND A NEW SET UP WAS STARTED AT 6:47 PM; HOWEVER AT APPROXIMATELY 8:00 PM, ANOTHER LEAK WAS NOTICED AT THE TRIFUSE. THE ENTIRE SET UP WAS REMOVED AND REPLACED, AND THERE WERE NO FURTHER LEAKS OR ISSUES. AS A RESULT, THE PATIENT REQUIRED BLOOD CULTURES AND UNSPECIFIED REPLACEMENT FLUIDS DUE TO THE DISCONTINUATION OF THE TPN. THERE WAS NO REPORT OF LASTING HARM AND THE ALL OF THE BLOOD CULTURES WERE NEGATIVE. ALTHOUGH REQUESTED NO FURTHER DETAILS OR INFORMATION WERE PROVIDED FROM THE CUSTOMER. THE EVENT OCCURRED IN THE PEDIATRIC ICU BONE MARROW UNIT.

  Patient problems: Venipuncture

  MAUDE report 8430406 ↗