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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFUTRONIX, LLC NIMBUS II FLEX AMBULATORY INFUSION PUMP
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INFUTRONIX, LLC NIMBUS II FLEX AMBULATORY INFUSION PUMP Back to Search Results
Model Number NIMBUS II FLEX
Device Problems Infusion or Flow Problem (2964); Pumping Problem (3016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2023
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record has been completed.The pump passed all previous tests.Complaint data was reviewed, there is one complaint pending on this device.The complaint in question prompted the filing of this mdr.Device return requested for further evaluation.
 
Event Description
On 12/08/2023, infutronix received a report that 4 pumps were not infusing completely.Requested the pumps to be returned for further evaluation.
 
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Brand Name
NIMBUS II FLEX AMBULATORY INFUSION PUMP
Type of Device
AMBULATORY INFUSION PUMP
Manufacturer (Section D)
INFUTRONIX, LLC
177 pine street
natick
Manufacturer (Section G)
INFUTRONIX, LLC
177 pine street
natick MA 01760
Manufacturer Contact
frederick lee
177 pine street
natick, MA 01760
5086502007
MDR Report Key18407271
MDR Text Key332496683
Report Number3011581906-2023-00764
Device Sequence Number1
Product Code FRN
UDI-Device Identifier00817170020093
UDI-Public00817170020093
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 01/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNIMBUS II FLEX
Device Catalogue NumberNIMBUS II FLEX
Device Lot Number210219600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received12/08/2023
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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