Accessories, Pump, Infusion
FDA adverse event reports and recall history for accessories, pump, infusion (product code MRZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 534
- Deaths
- 0
- Injuries
- 23
- Malfunctions
- 498
Reports per year
Source: FDA adverse event reports by year received, 2006–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-04-15Open, ClassifiedProcess control
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- 2009-12-03TerminatedSoftware design
Animas ezManager Max Diabetes Management System version 2.0.9
Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
- TerminatedUnder Investigation by firm
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- TerminatedUnder Investigation by firm
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- TerminatedUnder Investigation by firm
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- TerminatedUnder Investigation by firm
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in the U.S.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- TerminatedUnder Investigation by firm
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- TerminatedDevice Design
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
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