Alaris 30883Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403273957), received between Jun 14, 2019 and Aug 6, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150729 ↗
• MalfunctionAug 6, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150727 ↗
• MalfunctionJan 9, 2024Crack; Defective Component; Crack; Defective Component

  NO NEW INFORMATION: MATERIAL#: 30883 BATCH NUMBER#: 22095083. IT WAS REPORTED BY CUSTOMER THAT THEY HAD FOUR SEPARATE ISSUES: FIRST A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING, SECOND AND THIRD, TUBING HAD HOLES AND CRACKS IN IT. FOURTH A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE. VERBATIM# "WE HAVE HAD FOUR SEPARATE ISSUES: FIRST A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING, SECOND AND THIRD, TUBING HAD HOLES AND CRACKS IN IT. FOURTH A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE" CUSTOMER REPLY: CONFIRM WHETHER THE FOUR INCIDENTS HAPPENED IN THE SAME DATE. IF NOT, PLEASE PROVIDE THE DATES SEPARATELY. HAPPENED ON DIFFERENT DATES, WE WORK 12 HOUR SHIFTS SO TIMES AS ESTIMATES ONLY: 12/5/23 @ 2300- PCA MICRO BORE TUBING FOUND DISCONNECTED FROM SYRINGE, MEDICATION LEAKED ONTO FLOOR. 12/11/23 @ 0900- PCA TUBING MICRO BORE TUBING LEAKING MEDICATION ON FLOOR, DEFECTS FOUND IN PCA SMALL BORE TUBING. 12/12/23 @ 2130 -PCA TUBING MICRO BORE TUBING LEAKING MEDIATION ON FLOOR, DEFECTS FOUND IN PCA SMALL BORE TUBING. 12/14/23 @ 0800-LUER LOCK ON PCA SYRINGE BROKE OFF FROM PCA TUBING. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480473 ↗
• MalfunctionJan 9, 2024Disconnection; Material Separation; Disconnection; Material Separation

  NO NEW ADDITIONAL INFORMATION: MATERIAL#: 30883, BATCH NUMBER#: 22095083. IT WAS REPORTED BY CUSTOMER THAT THEY HAD FOUR SEPARATE ISSUES: FIRST A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING, SECOND AND THIRD, TUBING HAD HOLES AND CRACKS IN IT. FOURTH A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE. VERBATIM# "WE HAVE HAD FOUR SEPARATE ISSUES: FIRST A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING, SECOND AND THIRD, TUBING HAD HOLES AND CRACKS IN IT. FOURTH A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE". CUSTOMER REPLY: CONFIRM WHETHER THE FOUR INCIDENTS HAPPENED IN THE SAME DATE. IF NOT, PLEASE PROVIDE THE DATES SEPARATELY. HAPPENED ON DIFFERENT DATES, WE WORK 12 HOUR SHIFTS SO TIMES AS ESTIMATES ONLY: 12/5/23 @ 2300- PCA MICRO BORE TUBING FOUND DISCONNECTED FROM SYRINGE, MEDICATION LEAKED ONTO FLOOR. 12/11/23 @ 0900- PCA TUBING MICRO BORE TUBING LEAKING MEDICATION ON FLOOR, DEFECTS FOUND IN PCA SMALL BORE TUBING. 12/12/23 @ 2130 -PCA TUBING MICRO BORE TUBING LEAKING MEDIATION ON FLOOR, DEFECTS FOUND IN PCA SMALL BORE TUBING. 12/14/23 @ 0800-LUER LOCK ON PCA SYRINGE BROKE OFF FROM PCA TUBING. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480472 ↗
• MalfunctionJan 9, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT BD ALARIS PCA ADMINISTRATION SET WAS TUBING WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: "WE HAVE HAD FOUR SEPARATE ISSUES: FIRST A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING, SECOND AND THIRD, TUBING HAD HOLES AND CRACKS IN IT. FOURTH A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480470 ↗
• MalfunctionMar 25, 2021Stretched; Obstruction of Flow; Stretched; Obstruction of Flow

  IT WAS REPORTED THAT THE PCA ASV MICROBORE TUBING HAD BALLOONED NEAR WHERE IT ENTERED INTO THE CHANNEL, AND THE PUMP WAS STOPPED WITH THE REMAINING "28.6ML" OF "DOXORUBICIN". THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DATE REPORTED: 2/25; EXTENT OF HARM: REACHED THE INDIVIDUAL: BALLOONING OF IV TUBING PRODUCT. ITEM: ALARIS PUMP IV MODULE & BD ALARIS 3-PORT TUBING: ITEM AND LOT NUMBER: BEING INVESTIGATED CURRENTLY. ITEM CURRENTLY BEING REVIEWED BY CLINICAL ENGINEERING ALONGSIDE WITH THE ALARIS CHANNEL. O DOXORUBICIN MEDICATION PUMP CONTINUED TO STATE THAT "PATIENT SIDE WAS OCCLUDED",NO VISIBLE OCCLUSION OR BENT TUBING, ONCE I OPENED THE CHANNEL ON PUMP, VISIBLE BALLON ON TUBING THAT GOES INSIDE CHANNEL. PUMP WAS STOPPED WITH 28.6ML REMAINING OF MEDICATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571255 ↗
• MalfunctionJan 15, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE PCA ASV MICROBORE TUBING WOULD NOT FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING WILL NOT FLUSH."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11182501 ↗
• MalfunctionMay 7, 2020Failure to Prime

  NURSE WAS UNABLE TO GET PCA TUBING TO PRIME. MANUFACTURER RESPONSE FOR PCA TUBING, BD PCA ADMINISTRATION SET (PER SITE REPORTER). QUALITY EVENT REPORT EMAILED TO CUSTOMER FEEDBACK <[email protected]>. RETURN EMAIL RECEIVED FROM CUSTOMER ADVOCACY COMPLAINT MANAGEMENT. COMPLAINT FILE (B)(4). PRODUCT RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10032218 ↗
• MalfunctionJun 14, 2019Device Markings/Labelling Problem; Human-Device Interface Problem; Device Markings/Labelling Problem; Human-Device Interface Problem

  THE PATIENT WAS POST-OPERATIVE FROM BACK SURGERIES. NURSING HAD THOUGHT THE EPIDURAL INFUSION WAS IV TUBING, AND ATTACHED THE EPIDURAL TUBING TO THE PATIENT'S MIDLINE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701902 ↗