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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL; PUMP, INFUSION
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NULL; PUMP, INFUSION Back to Search Results
Device Problems Failure to Deliver (2338); Inaccurate Delivery (2339)
Patient Problem Dyspnea (1816)
Event Date 02/22/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported the pump cartridge is still full.Patient reports that they changed cartridge, successfully primed tubing and thought everything was working fine.States they did put in fresh batteries and pump did say it was running.Pump never gave any alarms alerts and patient did not see any blockages in tubing.However, today when patient went to change cartridge, it was still full.Patient reports feeling more shortness of breath during past 2 days but is feeling fine now.
 
Manufacturer Narrative
Other, other text: additional information is provided for h.2 and h.6.No product was returned.The investigation determined the most probable cause for the symptoms is due to improper programming of the pump, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.No serial number was provided; therefore, a history record review could not be conducted.
 
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Type of Device
PUMP, INFUSION
Manufacturer (Section G)
NULL
MDR Report Key16661083
MDR Text Key312532549
Report Number3012307300-2023-03363
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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