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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PCA PUMP; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. CADD LEGACY PCA PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 6300
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
(b)(6).Unknown.One device was received for evaluation.Visual inspection found housing damage.There was no evidence in the event history log.Functional testing was able to verify and duplicate the reported problem.It was determined that the backup capacitor 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 1720.There was no patient involvement.
 
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Brand Name
CADD LEGACY PCA 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 Key19092898
MDR Text Key340398125
Report Number3012307300-2024-02455
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
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 Number6300
Device Catalogue Number21-6300-14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2024
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/28/2009
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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