Alaris 10800173Recalls & reported problems
BD Switzerland Sàrl · PCA Administration Kit Reusable Monoject Plunger Rod, Kit Contents: Administration Set, Model 30853 with: Microbore Tubing Segment, Check Valve, Anti-siphon Valve, Reusable Monoject Plunger Rod (Compatible with Monoject Syringe Barrel) 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
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403234385), received between Mar 1, 2019 and Feb 26, 2020 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 Leak10
- Crack5
- Excess Flow or Over-Infusion1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Consequences Or Impact To Patient9
- Inadequate Pain Relief1
- No Information1
- Pain1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE CONNECTION BY THE CHECK VALVE CRACKED AND LEAKED DURING USE IN THE INTENSIVE CARE UNIT (ICU). THERE WAS A DELAY IN TREATMENT DUE TO CHANGING OUT OF THE IV TUBING SET TO A NEW ONE. ALTHOUGH IT WAS NOTED THAT THERE WAS A DELAY IN TREATMENT, IT WAS ALSO CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9759253 ↗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 9371666 ↗MalfunctionOct 28, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING SET HAD A HOLE THAT LEAKED DURING A DILAUDID INFUSION WHICH CAUSED THE PATIENT NOT TO RECEIVE THE ENTIRE DILAUDID MEDICATION DOSE. IT IS UNKNOWN HOW MUCH WAS RECEIVED BY THE PATIENT. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9247180 ↗MalfunctionSep 26, 2019Fluid/Blood Leak; Excess Flow or Over-Infusion; Fluid/Blood Leak; Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE TUBING SET LEAKED FROM THE ENGAGEMENT AT THE Y-SITE DURING A DILAUDID AND IV FLUID INFUSION. IT WAS CLARIFIED THAT THE TUBING SET DID NOT SEPARATE AS INITIALLY REPORTED. THE PATIENT DID NOT RECEIVE ANY OF THE IV FLUID FLUSH BAG AND IT IS UNDETERMINED WHETHER THE PATIENT RECEIVED THE DILAUDID MEDICATION AS ORDERED. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9123138 ↗MalfunctionJul 23, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE IV TUBING LEAKED AND DISCOVERED THERE WAS A HOLE WHILE IN USE ON A PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8816919 ↗MalfunctionJul 9, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUB CRACKED AND LEAKED.
Patient problems: No Information
MAUDE report 8771903 ↗MalfunctionJul 3, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT A PCA TUBING SET THAT WAS INFUSING HYDROMORPHONE THROUGH THE PRIMARY SITE, AND CLINIMIX INFUSING THROUGH THE Y-SITE CONNECTOR WAS FOUND TO BE CRACKED AT THE HUB AND LEAKING. THE CLINICIAN CHANGED IT AND WHEN PRIMING THE NEW TUBING, THIS TUBING WAS FOUND TO BE LEAKING AS WELL. IT WAS FURTHER CONFIRMED DURING FOLLOW-UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT. CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE CONNECTING PORT ON LINE WHERE THE CINIMIX WAS ENTERING WAS CRACKED AND LEAKING OUT. THIS HAPPENED WITH 2 DIFFERENT LINES." AN INCOMPLETE DATE OF EVENT OF XX-JUN-2019 WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8760513 ↗MalfunctionJul 3, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT A PCA TUBING SET THAT WAS INFUSING HYDROMORPHONE THROUGH THE PRIMARY SITE, AND CLINIMIX INFUSING THROUGH THE Y-SITE CONNECTOR WAS FOUND TO BE CRACKED AT THE HUB AND LEAKING. THE CLINICIAN CHANGED IT AND WHEN PRIMING THE NEW TUBING, THIS TUBING WAS FOUND TO BE LEAKING AS WELL. IT WAS FURTHER CONFIRMED DURING FOLLOW-UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT. CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE CONNECTING PORT ON LINE WHERE THE CINIMIX WAS ENTERING WAS CRACKED AND LEAKING OUT. THIS HAPPENED WITH 2 DIFFERENT LINES." AN INCOMPLETE DATE OF EVENT OF XX-JUN-2019 WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8760511 ↗MalfunctionJun 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PCA TUBING LEAKED WHILE IN USE ON A PATIENT LOCATED ON THE MEDICAL SURGICAL UNIT. THE CUSTOMER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8686795 ↗InjuryMay 7, 2019Crack; Fluid/Blood Leak; Material Split, Cut or Torn; Crack; Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT PCA TUBING CRACKED AND LEAKED DILAUDID ONTO THE FLOOR. THE SET WAS BEING USED ON A PATIENT THAT WAS STATUS POST WOUND DEBRIDEMENT, WASHOUT, AND WOUND VAC PLACEMENT. THIS EVENT CAUSED THE PATIENT SEVERE PAIN, AS THEY DID NOT RECEIVE MOST OF THEIR DOSE. THERE WAS NO OTHER PATIENT HARM.
Patient problems: Inadequate Pain Relief; Pain; Therapeutic Effects, Unexpected
MAUDE report 8586419 ↗MalfunctionMar 1, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE CUSTOMER REPORTED THE PCA SET WAS "PUNCTURED". THE EVENT OCCURRED IN THE ONCOLOGY UNIT. ALTHOUGH REQUESTED THERE ARE NO ADDITIONAL DETAILS PROVIDED AT THIS TIME. THERE WAS NO INDICATION OF PATIENT HARM. A NOTED RECEIVED WITH THE PRODUCT DOCUMENTED; "DATE ADM (B)(6) 2019".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8382090 ↗
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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.
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