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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS HPCA PUMP; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. CADD SOLIS HPCA PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problem Inaccurate Flow Rate (1249)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
One device was received for evaluation.Visual inspection found the device to be in good condition.There was no evidence in the event history log.Functional testing was unable to verify or duplicate the reported problem.The device passed all functional testing.The service history review identified no indication that the complaint was related to a service of the device within the review period.
 
Event Description
It was reported there is an issue with the flow rate accuracy.There was patient involvement and unknown patient harm/adverse event reported.
 
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Brand Name
CADD SOLIS HPCA PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan ln n
minneapolis, MN 55442
2247062300
MDR Report Key19055603
MDR Text Key339679965
Report Number3012307300-2024-02163
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2110
Device Catalogue Number21-2111-0300-09JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2024
Date Manufacturer Received03/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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