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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS HPCA; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. CADD SOLIS HPCA; PUMP, INFUSION Back to Search Results
Catalog Number 21-2111-0402-02L
Device Problems Break (1069); Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2024
Event Type  malfunction  
Event Description
It was reported that it does not detect the cassette loch and the membrane is broken.There was unknown patient involvement and unknown patient harm/adverse event reported.
 
Manufacturer Narrative
E1: (b)(6).One device was received for investigation.The device was visually inspected and functionally tested.A damaged dso sensor was found and found that the pump can't recognize between being latched and unlatched.This is to a faulty latch sensor.The latch sensor will be replaced.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.
 
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Brand Name
CADD SOLIS HPCA
Type of Device
PUMP, INFUSION
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 Key19092991
MDR Text Key340684542
Report Number3012307300-2024-02460
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K130394
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 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number21-2111-0402-02L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2023
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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