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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS HPCA PUMPS - 2110; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. CADD SOLIS HPCA PUMPS - 2110; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problem Defective Alarm (1014)
Patient Problem Insufficient Information (4580)
Event Date 11/01/2023
Event Type  malfunction  
Manufacturer Narrative
One device was received for evaluation.Visual inspection found no physical damage.Functional testing was conducted.Upon review, the reported problem was duplicated.It was determined that the defective mpu board was the root cause.The mpu board was replaced.The service history review identified no indication that the complaint was related to a service of the device within the review period.H3: device not received by manufacturer.B3: date of event is unknown.
 
Event Description
It was reported that the device exhibited error 45639.No adverse patient effects were reported by the customer.
 
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Brand Name
CADD SOLIS HPCA PUMPS - 2110
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 Key18322893
MDR Text Key330468003
Report Number3012307300-2023-12044
Device Sequence Number1
Product Code MEA
UDI-Device Identifier15019517154290
UDI-Public15019517154290
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2023
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 Manufacturer11/28/2023
Date Manufacturer Received11/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2021
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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