Alaris 30873Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10885403273940), received between Nov 6, 2018 and Mar 19, 2026 — classified as 3 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE BD PCA ASV MICROBORE CV HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PCA SET 30873 WAS INFUSING, NURSE INADVERTENTLY REMOVED THE FLUID LINE FROM THE Y-SITE, DID NOT CAP AND CONTINUED TO GIVE PCA DRUG, PATIENT EXPERIENCED SUDDEN ONSET OF SHORTNESS OF BREATH. CLINICAL ERROR WAS DISCOVERED, LINE CLAMPED AND PATIENT WAS GIVEN IMMEDIATE INTERVENTIONS INCLUDING VQ SCAN THAT WAS NEGATIVE. PATIENT RECOVERED WITHOUT FURTHER COMPLICATION.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 24643304 ↗
• MalfunctionFeb 20, 2026Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406086 ↗
• MalfunctionDec 10, 2024Complete Blockage; Complete Blockage

  MATERIAL # 30873. BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE RECENT UPGRADE OF THE ALARIS PUMPS, NURSES ARE HAVING OCCLUSION ISSUES WITH THE PCA SET. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REQUESTING TROUBLESHOOTING ASSISTANCE WITH THE ALARIS PCA SET (REF 30873). STATES SINCE THE RECENT UPGRADE OF THE ALARIS PUMPS, NURSES ARE HAVING OCCLUSION ISSUES WITH THE PCA SET. THE ALARM STATES OCCLUSION ON THE PATIENT SIDE AND IT HAS HAPPENED WITH AT LEAST 50% OF THEIR PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895401 ↗
• MalfunctionDec 10, 2024Complete Blockage; Complete Blockage

  MATERIAL # 10800175, BATCH # 24066698. IT WAS REPORTED BY CUSTOMER THAT THE RECENT UPGRADE OF THE ALARIS PUMPS, NURSES ARE HAVING OCCLUSION ISSUES WITH THE PCA SET. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REQUESTING TROUBLESHOOTING ASSISTANCE WITH THE ALARIS PCA SET (REF (B)(4) STATES SINCE THE RECENT UPGRADE OF THE ALARIS PUMPS, NURSES ARE HAVING OCCLUSION ISSUES WITH THE PCA SET. THE ALARM STATES OCCLUSION ON THE PATIENT SIDE AND IT HAS HAPPENED WITH AT LEAST 50% OF THEIR PATIENTS. CUSTOMER RESPONSE ON (B)(6) 2024. 1. IN YOUR PREVIOUS RESPONSE, IT WAS MENTIONED THAT THE MOST RECENT EVENT DATE WAS 11-25-2024. COULD YOU PLEASE CONFIRM IF ANY EARLIER EVENTS WERE REPORTED TO BD? IF SO, PLEASE PROVIDE THE COMPLAINT NUMBER. IF NOT, COULD YOU PROVIDE THE EVENT DATES IN THE FORMAT (MM-DD-YYYY), IF AVAILABLE? THIS EVENT ALSO OCCURRED ON 11-19-2024, 11-21-2024, AND 11-25-2024. THERE WERE ADDITIONAL EVENT DATES, BUT THESE ARE THE ONLY DATES IN WHICH IT WAS DIRECTLY REPORTED TO ME. MEREDITH- DO YOU HAVE A COMPLAINT NUMBER FROM THE REPORT THAT YOU PREVIOUSLY MADE WITH TECHNICAL SUPPORT? 2. THE PROVIDED LOT# 24066698 DOES NOT MATCH WITH MATERIAL# 30873 BUT CORRESPONDS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895289 ↗
• MalfunctionDec 10, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895231 ↗
• MalfunctionDec 10, 2024Complete Blockage; Complete Blockage

  MATERIAL#: 30873, BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE RECENT UPGRADE OF THE ALARIS PUMPS, NURSES ARE HAVING OCCLUSION ISSUES WITH THE PCA SET. RCC RECEIVED A COMPLAINT VIA EMAIL. REQUESTING TROUBLESHOOTING ASSISTANCE WITH THE ALARIS PCA SET (REF: 30873). STATES SINCE THE RECENT UPGRADE OF THE ALARIS PUMPS, NURSES ARE HAVING OCCLUSION ISSUES WITH THE PCA SET. THE ALARM STATES OCCLUSION ON THE PATIENT SIDE AND IT HAS HAPPENED WITH AT LEAST 50% OF THEIR PATIENTS. CUSTOMER RESPONSE ON (B)(6) 2024. 1. IN YOUR PREVIOUS RESPONSE, IT WAS MENTIONED THAT THE MOST RECENT EVENT DATE WAS 11-25-2024. COULD YOU PLEASE CONFIRM IF ANY EARLIER EVENTS WERE REPORTED TO BD? IF SO, PLEASE PROVIDE THE COMPLAINT NUMBER. IF NOT, COULD YOU PROVIDE THE EVENT DATES IN THE FORMAT (MM-DD-YYYY), IF AVAILABLE? THIS EVENT ALSO OCCURRED ON 11-19-2024, 11-21-2024, AND 11-25-2024. THERE WERE ADDITIONAL EVENT DATES, BUT THESE ARE THE ONLY DATES IN WHICH IT WAS DIRECTLY REPORTED TO ME. MEREDITH- DO YOU HAVE A COMPLAINT NUMBER FROM THE REPORT THAT YOU PREVIOUSLY MADE WITH TECHNICAL SUPPORT? 2. THE PROVIDED LOT#: 24066698 DOES NOT MATCH WITH MATERIAL#: 30873 BUT CORRESPONDS TO MATERIAL#: 10800175. COULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895193 ↗
• MalfunctionMay 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PCA ADMINISTRATION 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. (B)(6) REGARDING AN ISSUE WITH PCA TUBING LEAKING. I BELIEVE THE PRODUCT # THEY ARE USING IS 30873. THE SET WAS NOT SAVED TO SEND INTO BD.

  Patient problems: Insufficient Information

  MAUDE report 19368010 ↗
• MalfunctionApr 16, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113608 ↗
• MalfunctionAug 8, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED WHILE USING BD PCA SET Y CONN CHECK VLV 90 INCH THERE WERE CRACKS THAT CAUSED LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THERE IS A CRACK IN VALVE CONNECTION, WHICH HAS CAUSED LEAKAGE. AWARENESS DATE: 07/19/23.

  Patient problems: Insufficient Information

  MAUDE report 17480899 ↗
• MalfunctionJul 14, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA ADMINISTRATION SET DISCONNECTS SPONTANEOUSLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCONNECTING ITSELF FROM THE IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17328950 ↗
• MalfunctionApr 8, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA ADMINISTRATION SET EXPERIENCED DEVICE DAMAGE CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE NOTED SINCE PT LINENS AND CLOTHING FOUND TO BE WET, INSPECTED LINES AND FOUND TO HAVE DRIPPING AND CRACK NOTED TO PCA LINE WHERE MAINTENCE FLUID WAS Y'D INTO PCA LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705183 ↗
• MalfunctionDec 7, 2022Crack; Crack

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA ADMINISTRATION SET EXPERIENCED DEVICE DAMAGE WHILE CONSIDERED OPERABLE, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD PCA ADMINISTRATION SET WAS FOUND BY THE BEDSIDE RN TO BE CRACKED AT THE PORT THAT WAS CONNECTED TO A PATIENT'S TPN AND INTRALIPID LINE. THERE WERE NO EVENTS THAT LED UP TO THE CRACK. NO HARM WAS REPORTED TO THE PATIENT. THE LINE WAS REPLACED WITH NO FURTHER PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936694 ↗
• MalfunctionDec 6, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS PCA ADMINISTRATION SET THE TUBING WAS BROKEN AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RNS NOTIFIED THAT PCA TUBING APPEARED TO BE BROKEN. UPON INSPECTION, LUER LOCK PART OF TUBING WAS STILL ATTACHED TO PATIENT IV, AND TUBING HAD BROKEN JUST BEFORE LUER LOCK JUNCTION. RNS HAD TO PRIME NEW TUBING SET, AND WASTE MEDICATION. 1.8ML (3.6MG) OF CONCENTRATED HYDROMORPHONE WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929205 ↗
• MalfunctionNov 30, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA ADMINISTRATION SET LEAKED FROM THE CONNECTION PORT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED ISSUE: LEAKING PCA TUBING ¿ IVF LEAKING FROM CONNECTION PORT OF THE PCA TUBING. CHANGED PRIMARY TUBING BUT STILL LEAKING. CHANGE PCA TUBING AND LEAK STOPPED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884191 ↗
• MalfunctionNov 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD PCA SET Y CONN CHECK VLV 90 INCH LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE IVF WAS LEAKING OUT OF THE PORT THAT CONNECTS IT TO THE PCA TUBING. CHANGED THE PRIMARY FLUID TUBING AND IT WAS STILL LEAKING. WE DECIDED THAT WE NEEDED TO CHANGE THE PCA TUBING. AFTER WE CHANGED THE PCA TUBING WE HAD NO MORE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15764796 ↗
• MalfunctionOct 4, 2022Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA ASV MICROBORE CV THE PRODUCT WAS DAMAGED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD 2 SETS OF BD PCA ADMINISTRATION SETS BREAK. BOTH BREAKS HAPPENED TO THE SAME PATIENT AT THE SAME PLACE IN THE SAME 24 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540814 ↗
• MalfunctionSep 29, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD PCA SET Y CONN CHECK VLV 90 INCH LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: 14 Y/O FEMALE PATIENT W/LEAKING Y-SITE OF PIV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506665 ↗
• MalfunctionAug 29, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA ASV MICROBORE CV LEAKAGE OCCURRED FROM A CRACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND THE PCA TUBING CRACKED AND LEAKING FROM WHERE THE TRIFUSE MEETS. BD PCA ADMINISTRATION SET REF# 30873 ¿ THE NURSE WENT INTO A PATIENT¿S ROOM AND FOUND THE PCA TUBING LEAKING AND FOUND A ¿CRACK¿ WHERE THE TRIFUSE MEETS THE PCA TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316253 ↗
• MalfunctionJun 2, 2022Crack; Crack

  IT WAS REPORTED THAT THE BD ALARIS PCA ADMINISTRATION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: CRACKED TUBING CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581253 ↗
• MalfunctionDec 20, 2021Defective Component; Defective Device; Defective Component; Defective Device

  IT WAS REPORTED WHEN USING THE BD ALARIS PCA ADMINISTRATION SET, THE DEVICE EXPERIENCED A DAMAGED AND DEFECTIVE PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DEFECTIVE PRODUCT REPORTED TO ME, BD PAC TUBING MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044433 ↗
• MalfunctionNov 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA ADMINISTRATION SET TUBING HAD A HOLE IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PER THE ACCOUNT, HOLE IN TUBING AROUND THE LUER LOCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788086 ↗
• MalfunctionAug 16, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PCA ASV MICROBORE CV HAD A HOLE IN THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THERE WAS A HOLE IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328582 ↗
• MalfunctionJun 15, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PCA SET Y CONN CHECK VLV 90 INCH EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 30873 BATCH/ LOT #: 20077668. ONE STAFF REPORT OF A MISSING LUER LOCK AND TUBING CONNECTOR ABOVE THE BACK CHECK VALVE. THE WHITE PLASTIC FITTING ABOVE THE BACK CHECK VALVE THAT CONNECTS TO THE TUBE SECTION TO THE LUER CONNECTOR WAS BROKEN OFF ABOVE THE BACK CHECK VALVE. THE BROKEN OFF SECTION WAS NOT INSIDE THE PACKAGING. DEFECT WAS DISCOVERED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005950 ↗
• MalfunctionMar 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A CRACK WAS FOUND IN THE PCA ASV MICROBORE CV TUBING SETS DISTAL END DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR NURSING TEAMS HAVE CAME ACROSS A TUBING SET THAT HAS CRACKED WHILE ON A PATIENT. FROM THE FEEDBACK I¿VE HEARD THE CRACK OCCURS AT THE CONNECTOR ON THE DISTAL END AND WAS NOTICED MORE THAN ONCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529953 ↗
• InjuryJan 21, 2021Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT 1 BD ALARIS¿ PCA MICROBORE TUBING SET IN AN UNSPECIFIED LOT, AND 2 SETS IN ANOTHER UNSPECIFIED LOT HAD CRACKS AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I¿M NOT SURE IF THE PCA ADMIN TUBING PRODUCT ROLLS UP TO YOU OR NOT, BUT WE HAVE HAD SEVERAL INCIDENTS IN THE LAST 10 DAYS OR SO WHERE THE PCA TUBING CONNECTOR IS CRACKED CAUSING MEDICATION TO LEAK FROM THE TUBING."

  Patient problems: Awareness During Anesthesia; No Consequences Or Impact To Patient

  MAUDE report 11206413 ↗