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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 Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
E1: phone (b)(6).B3: unknown.One device was received for evaluation.Visual inspection found a degraded dso seal.Functional testing was able to verify and duplicate the reported problem.As soon as motor started alarm 41622 appeared with a red screen.It was determined that the defective cam sensor was the root cause and 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 the device exhibited error code 41622 with a red screen.The pump failed in a non-clinical setting, there was no 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 ln n
minneapolis, MN 55442
2247062300
MDR Report Key19093519
MDR Text Key340408728
Report Number3012307300-2024-02480
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeCA
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 04/11/2024
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 Model Number2110
Device Catalogue Number21-2111-0403-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2021
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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