Alaris, SmartSite, Texium 24602-B007TRecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Bag Access non-vented, Low Sorbing Tubing (PE line) 0.2 Micron Filter, Bonded Closed Male Luer with Priming Cap, 2 Y-Site, 300 cm (118 in) · Class 2
All models of Alaris, SmartSite, Texium (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885403240980), received between Jul 13, 2018 and May 13, 2020 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 Leak9
- Device Markings/Labelling Problem1
- Leak/Splash1
- Reflux within Device1
Patient problems
- No Consequences Or Impact To Patient9
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED FROM THE ONCOLOGY UNIT, DURING A 24 HOUR ETOPOSIDE 100MG/DOXORUBICIN 20MG/VINCRISTINE 0.4MG IN 250ML NORMAL SALINE INFUSION, THE FILTER TUBING SET LEAKED ON THE BEDDING AFTER 22 HOURS. THE EVENT OCCURRED ON THE SECOND DAY OF A 4 DAY CYCLE. UPON INSPECTION, THE LEAK APPEARED TO BE COMING FROM THE "PINHOLES" ON THE SIDE OF THE FILTER. THE BAG AND TUBING SET WERE CHANGED ABOUT EVERY 22 HOURS. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10053428 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED FROM THE ONCOLOGY UNIT, DURING A 24 HOUR ETOPOSIDE 100MG/DOXORUBICIN 20MG/VINCRISTINE 0.4MG IN 250ML NORMAL SALINE INFUSION, THE FILTER TUBING SET LEAKED AFTER 22 HOURS. UPON INSPECTION, THE LEAK APPEARED TO BE COMING FROM THE "PINHOLES" ON THE SIDE OF THE FILTER. THE BAG AND TUBING SET WERE CHANGED EVERY ABOUT EVERY 22 HOURS. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10053395 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED FROM THE ONCOLOGY FLOOR, DURING A 24 HOUR ETOPOSIDE 120MG/DOXORUBICIN 24MG/VINCRISTINE 0.4MG IN 500ML NORMAL SALINE INFUSION, THE FILTER LEAKED. THE EVENT OCCURRED ON THE LAST DAY OF THE 4 DAY CYCLE. UPON INSPECTION, THE LEAK APPEARED TO BE COMING FROM THE "PINHOLES" ON THE SIDE OF THE FILTER. GAUZE WAS WRAPPED AROUND THE FILTER TO STOP THE LEAK. THE BAG AND TUBING SET WERE CHANGED ABOUT EVERY 22 HOURS. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051073 ↗MalfunctionMay 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED FROM THE ONCOLOGY FLOOR DURING A 24 HOUR ETOPOSIDE 100MG/DOXORUBICIN 22MG/VINCRISTINE 0.4MG IN 250ML NORMAL SALINE INFUSION, THE TUBING SET LEAKED. THE EVENT OCCURRED ON THE LAST DAY OF THE 4 DAY CYCLE. UPON INSPECTION, THE LEAK APPEARED TO BE COMING FROM THE "PINHOLES" ON THE SIDE OF THE FILTER. GAUZE WAS WRAPPED AROUND THE FILTER TO STOP THE LEAK. THE BAG AND TUBING SET WERE CHANGED ABOUT EVERY 22 HOURS. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10045061 ↗MalfunctionJun 28, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE TUBING WAS MISLABELED. THE LABELING STATED THERE WAS A BACK CHECK VALVE, BUT THE SET DID NOT HAVE A BACK CHECK VALVE. ALTHOUGH REQUESTED, THERE WERE NO FURTHER DETAILS OR INFORMATION PROVIDED AND NO REPORT OF HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8745616 ↗MalfunctionJun 21, 2019Reflux within Device; Reflux within Device
IT WAS REPORTED THAT THE SECONDARY INFUSION UNEXPECTEDLY STARTED TO BACK FLOW INTO THE DRIP CHAMBER OF THE PRIMARY LINE. ALTHOUGH REQUESTED, THERE WERE NO FURTHER DETAILS OR INFORMATION PROVIDED AND NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8724992 ↗MalfunctionNov 29, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT A LEAK OCCURRED IN THE ONCOLOGY UNIT DURING A PUMP INFUSION OF A 500ML BAG OF NORMAL SALINE CONTAINING ETOPOSIDE 62.5MG, DOXORUBICIN 12MG, AND VINCRISTINE 0.35MG WHICH WAS RUNNING AT 46ML/HR. THE BAG WAS HUNG ON (B)(6) AT 0251 AND THE LEAK AT THE LOW SORB INFUSION SET WITH FILTER /TEXIUM WAS NOTED ON (B)(6) AT 1220. SPECIFICALLY, THE LEAK WAS COMING FROM THE BACK OF THE FILTER WHERE THERE IS A CIRCULAR PART OF THE PLASTIC. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8115467 ↗MalfunctionNov 28, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT A LEAK OCCURRED IN THE ONCOLOGY UNIT DURING A PUMP INFUSION OF A 500ML BAG OF NORMAL SALINE CONTAINING ETOPOSIDE 62.5MG, DOXORUBICIN 12MG, AND VINCRISTINE 0.35MG WHICH WAS RUNNING AT A RATE OF 46ML/HR. THE BAG WAS HUNG ON (B)(6) AT 0248 AND THE LEAK AT THE LOW SORB INFUSION SET WITH FILTER /TEXIUM WAS NOTED ON (B)(6) AT 1230. SPECIFICALLY, THE LEAK WAS COMING FROM THE BACK OF THE FILTER WHERE THERE IS A CIRCULAR PART OF THE PLASTIC. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8112786 ↗MalfunctionNov 28, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT A LEAK OCCURRED IN THE ONCOLOGY UNIT DURING A PUMP INFUSION OF A 500ML BAG OF NORMAL SALINE CONTAINING ETOPOSIDE 62.5MG, DOXORUBICIN 12MG, AND VINCRISTINE 0.35MG WHICH WAS RUNNING AT A RATE OF 46ML/HR. THE BAG WAS HUNG ON (B)(6) 2018 AT 0010 AND THE LEAK (FROM THE CENTER OF THE CIRCULAR AREA NEAR THE END OF THE FILTER) WAS NOTED ON (B)(6) 2018 AT APPROXIMATELY 1115 AFTER INFUSING FOR APPROXIMATELY 11 HOURS. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8111334 ↗MalfunctionOct 29, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A CHEMO SPILL WAS CAUSED BY THE SET LEAKING AT THE LUER-LOCK SITE WHERE THE TEXIUM ATTACHES. NO CRACKS WERE SEEN. THE SET WAS ATTACHED TO A PATIENT'S CHEST PORT AT THE TIME OF THE LEAK. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8016912 ↗MalfunctionOct 24, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT FLUID LEAKED FROM THE IV SET AT THE ENGAGEMENT TO THE FILTER NEAR THE END OF AN ETOPOSIDE INFUSION. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8000841 ↗MalfunctionJul 13, 2018Leak/Splash; Leak/Splash
RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA, WHICH STATES ¿THE SPECIALIZED IV TUBING FOR VP-16 CHEMOTHERAPY AGENT HAD A PIN HOLE LEAK IN THE PORTION OF THE TUBING THAT LOADS INTO THE ALARIS PUMP CASSETTE. THE HOLE WAS NOT FOUND UPON VISUAL INSPECTION PRIOR TO LOADING THE TUBING, BUT IT BEGAN TO LEAK ONCE THE DOOR TO THE CASSETTE WAS CLOSED. WHEN I OPENED THE DOOR I SAW A PIN HOLE SIZE OPENING APPROXIMATELY 0.5 CM BELOW WHERE THE TUBING CONNECTS TO THE ADAPTER AT THE TOP. THERE WAS LIQUID SPRAYING UP AND OUTWARDS TO THE PATIENT'S CHAIR, THE PATIENT'S UPPER ARM, THE FLOOR AND THE SLEEVE OF THE GOWN NURSE WAS WEARING." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2018 WAS PROVIDED. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7686345 ↗
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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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