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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  
Event Description
It was reported that the low rate is out of tolerance.There was unknown patient involvement and unknown patient harm/adverse event reported.
 
Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.One device was received.A visual test was performed - found that damaged dso seal.To resolve this issue the dso seal will be replaced.Functional test was performed.Occlusion and accuracy test was performed- tests passed.The reported problem could not be duplicated.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The dso seal will be replaced.No further action was taken as the complaint was not confirmed/replicated.
 
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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 lane north
minneapolis, MN 55442
2247062300
MDR Report Key19100053
MDR Text Key340797453
Report Number3012307300-2024-02549
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeFR
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 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2110
Device Catalogue Number21-2112-0300-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2024
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2017
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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