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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
Catalog Number 21-2111-0100-51
Device Problem Failure to Infuse (2340)
Patient Problems Bradycardia (1751); Pulmonary Hypertension (4460)
Event Date 05/09/2021
Event Type  malfunction  
Event Description
It was reported that the pump failed to infuse as programmed.Event caused patient to have profound hypotension and bradycardia.It is unknown no medical or surgical intervention was reported.
 
Manufacturer Narrative
Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No causes or potential causes of the customer's reported problem were found during the review of service and repair record.The tampered seal label was missing.Scratches and cracks found on liquid crystal display (lcd) lens screen: battery door was missing.No evidence found in the device history log.Device passed the functional tests but failed the three accuracy tests.The device was found to over infuse.The reported problem was not confirmed.However, the device was able to infuse however it was over infusing.The root cause of the reported problem could not be confirmed.However, the technician found other problems.The technician recommended expulsor to be trimmed and replaced the air detector for preventive measure.
 
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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 Key17019567
MDR Text Key316116793
Report Number3012307300-2023-05822
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 Nurse
Type of Report Initial
Report Date 05/30/2023
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 Catalogue Number21-2111-0100-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/18/2021
Initial Date FDA Received05/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
Patient SexMale
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