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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 Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2024
Event Type  malfunction  
Event Description
It was reported the device failed the leakage test.Please assess and quote repair.There was no patient involvement.
 
Manufacturer Narrative
E1: (b)(6).One device was received for evaluation.Visual inspection found the device to be in good condition.Functional testing was unable to duplicate the reported issue.There was no fault found.The service history review identified no indication that the complaint was related to a service of the device within the review period.
 
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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 Key18889612
MDR Text Key337488591
Report Number3012307300-2024-01305
Device Sequence Number1
Product Code MEA
UDI-Device Identifier15019517154290
UDI-Public15019517154290
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K170982
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 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2110
Device Catalogue Number21-2111-0402-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2020
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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