Alaris 10013890Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403232268), received between Nov 7, 2018 and Jun 9, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

2 FDA recall records name this device's identifier, 2 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2020Material Separation; Material Separation

  IT WAS REPORTED FROM THE FIRST HILL CAMPUS OF THE SWEDISH CANCER INSTITUTE TREATMENT CENTER THAT THE TUBING HAD SEPARATED FROM THE SAFETY CLAMP. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136453 ↗
• MalfunctionMay 12, 2020Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE IV TUBING SET APPEARED TO HAVE MICRO HOLES WHERE FLUID SEEMED TO BE SEEPING FROM THE TUBING WHERE THE CARTRIDGE IS INSERTED INTO PUMP

  Patient problems: No Information

  MAUDE report 10046525 ↗
• MalfunctionMay 5, 2020Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  IT WAS REPORTED THAT DURING AN INFUSION THE TUBING APPEARED TO HAVE MICRO HOLES WHERE THE FLUID APPEARED TO SEEP FROM THE TUBING WHERE THE CARTRIDGE IS INSERTED INTO THE PUMP. IT WAS REPORTED NO MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026616 ↗
• MalfunctionApr 29, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE GOING TO HANG THE CHEMOTHERAPY INFUSION 1L NS BAG MIXED WITH CISPLATIN, CYTOXAN, AND VEPESID, THE PRIMARY TUBING SET SPIKE BROKE. THE CHEMOTHERAPY DRUG SPILLED INSIDE OF THE BAG IT WAS CARRIED IN, BUT DID NOT SPILL OUTSIDE OF THE CARRIER BAG. THIS OCCURRED AT INPATIENT ONCOLOGY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10011280 ↗
• MalfunctionApr 27, 2020Break; Break

  IT WAS REPORTED THAT WHILE PRIMING THE CHEMOTHERAPY INFUSION 1L NS BAG MIXED WITH CISPLATIN, CYTOXAN, AND VEPESID, THE PRIMARY TUBING SET SPIKE BROKE. IT WAS REPORTED THAT THIS OCCURRED TWICE ON UNKNOWN DATES, AT INPATIENT ONCOLOGY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10000524 ↗
• MalfunctionApr 27, 2020Break; Break

  IT WAS REPORTED THAT WHILE PRIMING THE CHEMOTHERAPY INFUSION 1L NS BAG MIXED WITH CISPLATIN, CYTOXAN, AND VEPESID, THE PRIMARY TUBING SET SPIKE BROKE. IT WAS REPORTED THAT THIS OCCURRED TWICE ON UNKNOWN DATES, AT INPATIENT ONCOLOGY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10000522 ↗
• MalfunctionJan 4, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A TUBING LEAK. THERE WAS NO REPORT OF HARM. THE SPECIFIC EVENT DATE WAS NOT PROVIDED HOWEVER IT OCCURRED WITH THE LAST COUPLE OF YEARS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8220042 ↗
• MalfunctionNov 7, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED TUBING CRACKED AND LEAKED WHILE INFUSING CHEMO. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8048442 ↗