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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 Defective Alarm (1014)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3, g4, unknown.(b)(6).One device was received for evaluation.Visual inspection found a swollen dso seal.Functional testing was able to duplicate the reported problem.It was determined that the defective piezo was the root cause.The piezo was replaced.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 that the device's buzzer is not working.There was unknown patient involvement.
 
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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 n
minneapolis, MN 55442
2247062300
MDR Report Key18691679
MDR Text Key335196204
Report Number3012307300-2024-00752
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2110
Device Catalogue Number21-2111-0402-02L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2020
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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