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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD LEGACY PLUS PUMP; PUMP, INFUSION

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ST PAUL CADD LEGACY PLUS PUMP; PUMP, INFUSION Back to Search Results
Model Number 6500
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter: (b)(6).Occupation: product complaint analyst.
 
Event Description
Information was received indicating that a smiths medical cadd legacy plus pump did not infuse an epoch-r medication.The patient reported that the pump was never turned off at any point.There was no patient injury.
 
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Brand Name
CADD LEGACY PLUS PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11619918
MDR Text Key243966467
Report Number3012307300-2021-02869
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10610586019647
UDI-Public10610586019647
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982836
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6500
Device Catalogue Number21-6500-51
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/08/2021
Initial Date FDA Received04/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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