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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA PUMPS; PUMP, INFUSION, PCA

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ST PAUL CADD SOLIS HPCA PUMPS; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problems Inaccurate Flow Rate (1249); Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No causes or potential causes of the customers reported problem were found during the review of the service and repair records.A product sample was received for evaluation.Visual inspection showed missing sticker seal.During functional check, the reported problem not duplicated.Performed no disposable alarm testing of pump as per procedure.However, running three accuracy tests, the pump was found to be over delivering instead of under delivering to the manufacturing specifications.Checked the returning communication module and it was defective.Trimmed expulsor down to bring the delivery accuracy closer to nominal of a range and customer purchased a new communication module.
 
Event Description
It was reported that device had low volume and failed accuracy test, including the communication module.No patient injury reported.
 
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Brand Name
CADD SOLIS HPCA PUMPS
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16707163
MDR Text Key312962455
Report Number3012307300-2023-03827
Device Sequence Number1
Product Code MEA
UDI-Device Identifier15019517099690
UDI-Public15019517099690
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2110
Device Catalogue Number21-2111-0401-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2022
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/20/2023
Initial Date FDA Received04/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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