Alaris 30853Recalls & reported problems
BD Switzerland Sàrl · PCA Administration Set, Microbore Tubing, Segment Check Valve, Anti-siphon Valve 178 cm (70 in) · Class 2
All models of Alaris (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403273995), received between Oct 4, 2019 and Mar 18, 2020 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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
Device problems
- Fluid/Blood Leak8
- Crack4
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient6
- No Information2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2020Crack; Crack
IT WAS REPORTED THAT TUBING WAS CRACKED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT AND/OR PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Information
MAUDE report 9851335 ↗MalfunctionMar 16, 2020Crack; Crack
THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH NO OTHER INFORMATION PROVIDED. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.
Patient problems: No Information
MAUDE report 9835735 ↗MalfunctionJan 13, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT TUBING WAS SLICED. THE RN WAS IN THE ICU, SETTING UP THE PCA TUBING. SHE STARTED TO PRIME THE PCA PUMP AND NOTICED THE TUBING WAS LEAKING. THE RN STOPPED THE PUMP AND CHANGED THE TUBING. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT OR HARM AS A RESULT OF THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9582242 ↗MalfunctionNov 25, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A PATIENT WAS ON A PCA PUMP. THE PHYSICIAN'S ASSISTANT NOTIFIED THE NURSE THAT THE PCA PUMP TUBING WAS LEAKING ONTO THE FLOOR. THE NURSE ASSESSED THE TUBING LINE AND FOUND THAT THERE WAS A SMALL LEAK IN THE TUBING. THE TUBING WAS REMOVED. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO DELAY IN TREATMENT NOR ANY PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9371757 ↗MalfunctionNov 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PCA EXT TUBING LEAKED MULTIPLE TIMES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM. THE EVENT OCCURRED ON BMT . A NOTE ATTACHED TO BAG THAT STATED; "LEAKING, CHANGED MULTIPLE TIME, NEW TUBING LOT OBTAINED FROM ANOTHER UNIT , INFUSING FINE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9359311 ↗MalfunctionNov 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PCA EXT TUBING LEAKED MULTIPLE TIMES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM. THE EVENT OCCURRED ON BMT. A NOTE ATTACHED TO BAG THAT STATED; "LEAKING, CHANGED MULTIPLE TIME, NEW TUBING LOT OBTAINED FROM ANOTHER UNIT, INFUSING FINE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9359256 ↗MalfunctionNov 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PCA EXT TUBING LEAKED MULTIPLE TIMES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM. THE EVENT OCCURRED IN THE BMT. ( A NOTE ATTACHED TO BAG THAT STATED; "LEAKING, CHANGED MULTIPLE TIME, NEW TUBING LOT OBTAINED FROM ANOTHER UNIT , INFUSING FINE".)
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9358440 ↗MalfunctionNov 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PCA EXT TUBING LEAKED MULTIPLE TIMES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM. THE EVENT OCCURRED IN THE BMT. ( A NOTE ATTACHED TO BAG THAT STATED; "LEAKING, CHANGED MULTIPLE TIME, NEW TUBING LOT OBTAINED FROM ANOTHER UNIT , INFUSING FINE".)
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9358179 ↗MalfunctionOct 22, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE PRIMARY FLUSH TUBING SET LEAKED FROM THE SIDE OF THE BACK CHECK VALVE WHEN THE PCA INFUSION SET WAS ATTACHED TO THE PRIMARY FLUSH. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9220209 ↗MalfunctionOct 4, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE PCA TUBING SET WAS FOUND TO HAVE SMALL CRACKS WHICH CAUSED THE MEDICATION TO LEAK DURING USE ON A PATIENT. THE CUSTOMER FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE ADULT PATIENT FROM THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9156106 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page