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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA PUMPS; PUMP, INFUSION
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ST PAUL CADD SOLIS HPCA PUMPS; PUMP, INFUSION Back to Search Results
Catalog Number 21-2111-0100-51
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that there was an under delivery bolus, 18.4ml out of tolerance during testing.No patient injury reported.
 
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.A product sample was received for evaluation.Visual inspection showed the tamper seal and battery door were missing.During functional check, the reported complaint was duplicated.The pump was found to be over delivering to the manufacturing specifications.Root cause is unknown.Replaced expulsor.
 
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Brand Name
CADD SOLIS HPCA PUMPS
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16706446
MDR Text Key312976858
Report Number3012307300-2023-03805
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number21-2111-0100-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Was the Report Sent to FDA? No
Date Manufacturer Received01/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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