Alaris 20129ERecalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 10885403234903), received between Jul 12, 2018 and Nov 27, 2025 — classified as 7 injuries, 181 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (70 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT A FILTER BECOMING OCCLUDED DURING ADMINISTRATION OF SMOFLIPID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23667688 ↗
• MalfunctionNov 21, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT A FILTER BECOMING OCCLUDED DURING ADMINISTRATION OF SMOFLIPID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624892 ↗
• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED REPORTS INDICATING LEAKAGE FROM THE CONNECTION BETWEEN THE FILTER TUBING AND THE PRESSURE SENSING DISC TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636872 ↗
• MalfunctionJul 28, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I OBSERVED THAT A SMALL AIR BUBBLE BEFORE THE PRESSURE SENSING DISC EXPANDED INTO A LARGER BUBBLE AFTER PASSING THROUGH THE DISC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636871 ↗
• MalfunctionApr 22, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT PICC LINE HAD TPN AND SMOF INFUSING AND ANOTHER DRIP. THE SMOF WAS CLAMPED AND PAUSED DURING A MEDICATION INFUSION DUE TO INCOMPATIBILITY AND TURNED BACK ON AFTER THE MEDICATION HAD BEEN FLUSHED. A FEW MINUTES LATER, THE SMOF CHANNEL ALARMED "OCCLUDED". THERE WERE NO KINKS IN THE LINE, NOTHING WAS CLAMPED AND ALL THE OTHER FLUIDS WERE RUNNING. THE LIPID TUBING WAS REMOVED AND UNABLE TO BE MANNUALLY PUSHED THROUGH THE FILTER. THE FILTER WAS REPLACED AND FLUSHED WITH LIPIDS, RECONNECTED TO THE PICC AND INFUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887234 ↗
• MalfunctionFeb 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT FLUID NOTED TO BE LEAKING AT CONNECTION BETWEEN FILTER AND EXTENSION WITH SPIN-LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442736 ↗
• MalfunctionFeb 12, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: DESCRIBE THE EVENT OR PROBLEM (PLEASE PROVIDE AS MUCH DETAIL AS POSSIBLE: TUBING NOTED TO BE LEAKING FROM SMALL ADD ON FILTER ONE HOUR INTO ANTIBIOTIC INFUSION, ENOUGH TO CREATE PUDDLE ON PATIENT'S GOWN/CHAIR/FLOOR, NO OCCLUSION OR BACKFLOW NOTED IN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370733 ↗
• MalfunctionDec 5, 2024Leak/Splash; Leak/Splash

  MATERIAL # 20129E, BATCH # 24089016. IT WAS REPORTED BY CUSTOMER THAT 20129E, LEAKING AT THE LIPID FILTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAVE A DEFECTIVE TUBING, ITEM 20129E LOT (10)24089016, LEAKING AT THE LIPID FILTER, I HAVE THE PRODUCT IF YOU WANT ME TO SEND IT TO YOU. ADDITIONAL INFORMATION RECEIVED ON 15NOV. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN MM-DD-YYYY FORMAT? 11/12. 2. WHAT WAS THE IMPACT TO THE PATIENT? TUBING HAD TO BE CHANGED AND CENTRAL LINE WAS POTENTIALLY OPEN TO CONTAMINATION. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS NO. 4. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? LIPIDS 5. WAS THIS A CHEMOTHERAPY DRUG? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854888 ↗
• MalfunctionNov 27, 2024Leak/Splash; Leak/Splash

  MATERIAL # 20129E. BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE CONNECTION BETWEEN TWO PRODUCTS LEAKED WHILE THE PUMP WAS ACTIVE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE USE BD EXTENSION SET SMALLBORE TUBING 1.2 M LOW PROTEIN BINDING FILTER (REF 20129E) IN CONJUNCTION WITH BD EXTENSION SET AMBER TUBING (REF 10241342) FOR DELIVERY OF LIPID SOLUTIONS IN OUR NEONATAL INTENSIVE CARE UNIT. WE HAVE EXPERIENCED MULTIPLE (>5) INCIDENTS OVER THE PAST YEAR IN WHICH THE CONNECTION BETWEEN THESE TWO PRODUCTS LEAKED WHILE THE PUMP WAS ACTIVE. INITIALLY, THE SUSPECTED ISSUE WAS POSSIBLY OVERTIGHTENING BY EITHER PHARMACY COMPOUNDER OR NURSE. HOWEVER, THE REPEATED NATURE OF THESE EVENTS - EVEN AFTER ALERTING STAFF TO ENSURE ONLY TIGHTENING THE CONNECTION UNTIL IT STOPS - HAS GIVEN CAUSE TO THINK THIS MAY BE A PRODUCT ISSUE. WE ARE CONCERNED THAT THIS MAY AFFECT THE DELIVERED VOLUME AS WELL AS THE STERILITY OF THE SYSTEM IF THE CONNECTION IS NOT MAKING AN ADEQUATE SEAL. IS THIS A CONCERN THAT HAS ARISEN ELSEWHERE? ARE THERE ANY SUGGESTED TECHNIQUES ASIDE FROM EXISTING PRODUCT LITERATURE? ARE THESE TWO PRODUCTS COMPATIBLE? ARE THERE BETTER SOLUTIONS FOR ADMINISTRATION OF LIPIDS WHI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798478 ↗
• MalfunctionSep 27, 2024Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: LEAKING BACK TO INFLOW AFTER PRIMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323914 ↗
• MalfunctionJul 29, 2024Defective Component; Defective Component

  MATERIAL #: 20129E. BATCH #: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT HAVE FOUND THAT THE AMBER TUBING DOES NOT CONSISTENTLY SEAT PROPERLY WITH THE LIPID FILTERS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PATIENT - 1( (B)(4) ). BD EXTENSION SET AMBER TUBING, REF (B)(4), LOT: (10)24049060. NICU HAS PUT THE AMBER TUBING INTO PLACE TO LIGHT PROTECT INTRALIPIDS, SMOF, OMEGAVEN, AS WELL AS SECONDARY TPN SYRINGES. WE HAVE FOUND THAT THE AMBER TUBING DOES NOT CONSISTENTLY SEAT PROPERLY WITH THE LIPID FILTERS (BD (B)(4) ). THIS HAS BEEN FOUND ON 4 PATIENTS. THE ENDS OF THE LIPID FILTERS SEEM TO HAVE A DIFFERENT COLOR PLASTIC AND MAKE A FRICTION NOISE WHEN CONNECTED. THIS HAS ONLY BEEN FOUND WITH THE 1.2 MICRON FILTER NOT THE 0.2 MICRON FILTER (USED FOR TPN). DUE TO THE INCREASED RISK OF INFECTION AND SUBOPTIMAL NUTRITION WE HAVE PULLED THE PRODUCT. PLEASE LET US KNOW IF YOU ARE AWARE OF THIS PROBLEM AT ANY OTHER INSTITUTION(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851858 ↗
• MalfunctionMay 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CUSTOMER NOTED: WHILE PERFORMING CARES, NOTED INFANT'S SWADDLE WAS SLIGHTLY DAMP. TRACED LINES AND FELT MOISTURE ON LIPID FILTER. REPLACED FILTERED AND CHANGED OUT SWADDLE BLANKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402557 ↗
• MalfunctionApr 15, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: OUR CURRENT PRACTICE IS TO CHANGE LIPIDS SYRINGES, TUBING AND 1.2 MICRON FILTER Q24H BUT WE HAVE BEEN RECEIVING AN INCREASING NUMBER OF SAFETY REPORTS WHERE THE FILTERS ARE CAUSING OCCLUSIONS OR BLOCKING AND HAVE TO BE CHANGED SOONER THAN EXPECTED. THIS IS CONCERNING SINCE BOTH THE FILTER AND TUBING ARE OPEN SYSTEMS. WE USE ALARIS SYRINGE PUMPS WITH PRESSURE SENSING DISK TUBING AND WHEN WE IMPLEMENTED THE FILTERS WE CHOSE TO ATTACH THE FILTER TO THE END OF OUR INFUSION LINE, CLOSER TO THE INFANT. DO YOU HAVE ANY PRODUCT TESTING AVAILBLE TO HELP GUIDE OUR USE AND POSITIONING WITHIN THE SYSTEM OR ANY INFORMATION AS TO WHY THE FILTERS ARE OCCLUDING/BLOCKING AT LESS THE 24HRS OF USE?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112034 ↗
• MalfunctionApr 3, 2024Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM CLOGGED LIPID FILTER, FILTER REPLACED. PLEASE REFERENCE MEDLINE COMPLAINT (B)(4) ON ALL EMAILS. INJURIES OR ADVERSE EVENT: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032251 ↗
• MalfunctionApr 3, 2024Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM . REPORTED ISSUE: LIPID FILTER ALARMING OCCLUDED, FILTER REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032245 ↗
• MalfunctionMar 29, 2024Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT BD 7 INCH MIC EXT SET W/1.2MF LIPID FILTER IS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE PER CUSTOMER: LIPID FILTER CLOGGED, REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005788 ↗
• MalfunctionMar 25, 2024Complete Blockage; Complete Blockage

  MATERIALS: 20129E BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT LIPIDS WERE PAUSED FOR A MEDICATION FOR 15 MINS. WHEN THE LIPIDS WERE RESTARTED, THE FILTER WAS CLOTTED AND HAD TO BE REPLACED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE #: (B)(4). ITEM: 20129E. QUANTITY AFFECTED: 1 EA. SERIAL/LOT NUMBER: NA. PO #:(B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: LIPIDS WERE PAUSED FOR A MEDICATION FOR 15 MINS. WHEN THE LIPIDS WERE RESTARTED, THE FILTER WAS CLOTTED AND HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969011 ↗
• MalfunctionMar 13, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIALS: 20129E BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT ALARMING "OCCLUDED". REPLACED LIPID FILTER AND PROBLEM RESOLVED. VERBATIM: 200604135 - 4516935508 - 20129E INJURIES OR ADVERSE EVENT: NO MEDLINE REFERENCE #: (B)(4). ITEM: 20129E QUANTITY AFFECTED: 1 EA SERIAL/LOT NUMBER: NA PO #: 4516935508. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: ALARMING "OCCLUDED". REPLACED LIPID FILTER AND PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891900 ↗
• MalfunctionMar 13, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIALS: 20129E BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT REPORTED ISSUE PER CUSTOMER: PT PUMP ALARMING PT SIDE OCCLUDED, FIXED PRESSURE READING AFTER FILTER WAS REPLACED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO MEDLINE REFERENCE #: (B)(4). ITEM: 20129E QUANTITY AFFECTED: 1 EA PO #: 451693550. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: PT PUMP ALARMING PT SIDE OCCLUDED, FIXED PRESSURE READING AFTER FILTER WAS REPLACED. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891899 ↗
• MalfunctionMar 12, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM REPORTED ISSUE PER CUSTOMER: PT PUMP ALARMING OCCLUDED, WHEN TRYING TO DETACH, BLUE NAD WOULD NOT SEPARATE FROM LIPID FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891848 ↗
• MalfunctionMar 12, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 20129E, BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT PT PUMP ALARMING OCCLUDED, WHEN TRYING TO DETACH, BLUE NAD WOULD NOT SEPARATE FROM LIPID FILTER. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE #: (B)(4). ITEM: 20129E: QUANTITY AFFECTED: 1 EA. SERIAL/LOT NUMBER: NA. PO #: 4516935508. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: PT PUMP ALARMING OCCLUDED, WHEN TRYING TO DETACH, BLUE NAD WOULD NOT SEPARATE FROM LIPID FILTER. REPLY: THE EVENT DATE IS 02/19/24.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891847 ↗
• MalfunctionMar 7, 2024Complete Blockage; Complete Blockage

  NO FURTHER INFORMATION WAS PROVIDED. MATERIALS: 20129E BATCH#: 23119256 IT WAS REPORTED BY THE CUSTOMER THAT WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC [email protected] AND [email protected] ON ANY FUTURE COMMUNICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC [email protected] AND [email protected] ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: YES ITEM: 20129E QUANTITY AFFECTED: (B)(4) EA SERIAL/LOT NUMBER: (B)(6). PO : 4516935508 ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: LIPID FILTER OCCLUDED, SWITCHED TO NEW ONE AND ALARM FOR OCCLUSION STOPPED. CUSTOMER DISPOSITION REQUEST: REPLACEMENT ADDITIONAL INFORMATION RECEIVED ON 20-FEB-2024 MORNING, I AM FOLLOWING UP FROM A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CONCERN. PLEASE CONTACT THE CUSTOMER AND CC ME ON ANY FUTURE COMMUNICATION LAURA SELK GOOD MORNING, THE EVENT DATE WAS 02/03/24 AND I WILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862335 ↗
• MalfunctionMar 7, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT BD TUBE IV EXT W/FILTER- THE FILTER CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: FILTER CONTINUING TO CAUSE ALARM ON PUMP. ON FURTHER INVESTIGATION THE FILTER WAS CLOTTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858367 ↗
• MalfunctionMar 1, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD 7 INCH MIC EXT SET W/1.2MF FILTER OCCLUDED DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REFERENCE NUMBER (B)(4) THE FILTER RAN OCCLUDED WHILE INFUSING AND THE RN WAS NOT ABLE TO PRIME THE TUBING WITHOUT IT OCCLUDING. REFERENCE NUMBER (B)(4) THE FILTER RAN OCCLUDED WHILE INFUSING AND THE RN WAS NOT ABLE TO PRIME THE TUBING WITHOUT IT OCCLUDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818402 ↗
• MalfunctionFeb 21, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 20129E, BATCH#: UNKNOWN. IT WAS REPORTED, BY CUSTOMER, THAT CLOGGED LIPID FILTER TWICE ON NIGHT SHIFT. THERE WERE NO SERIOUS INJURIES TO THE PATIENT OR HEALTHCARE PROFESSIONAL. TREATMENT WAS COMPLETED BY CHANGING FILTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. REPORTED ISSUE, PER CUSTOMER: CLOGGED LIPID FILTER TWICE ON NIGHT SHIFT. THERE WERE NO SERIOUS INJURIES TO THE PATIENT OR HEALTHCARE PROFESSIONAL. TREATMENT WAS COMPLETED BY CHANGING FILTER. FOLLOW UP: PLEASE PROVIDE THE DATE OF EVENT? (B)(6) 2024. CAN YOU PROVIDE A BATCH NUMBER? UNFORTUNATELY, NURSING THREW THE PACKAGING AWAY AND BATCH NUMBER IS UNAVAILABLE. IS THERE ANY PHYSICAL SAMPLE OR SAMPLE PHOTOS/VIDEOS AVAILABLE? A PHYSICAL SAMPLE IS AVAILABLE TO BE RETURNED FOR EVALUATION. DID THE EVENT DIRECTLY OR INDIRECTLY INVOLVE A PATIENT OR USER? YES, THIS EVENT OCCURRED, WHILE IN USE WITH A PATIENT. BUT, NO HARM WAS DONE TO PATIENT. HAS THERE BEEN ANY PATIENT IMPACT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? NO. PLEASE CONFIRM, THE NUMBER OF OCCURRENCES. FILTER CLOGGED TWICE. AND THEN WAS SWITCHED OUT FOR A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18749420 ↗