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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 Inaccurate Delivery (2339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths cadd-legacy® pca pump failed the delivery accuracy test, causing a high delivery rate.There was no reported serious injury to the patient.
 
Manufacturer Narrative
Device evaluation: one smiths medical cadd legacy pca pump was returned for analysis with no damage.Event log history was performed and showed that three 20ml bolus tests may have been performed prior to the pumps return to smiths medical.During analysis, the customer's concern regarding failed accuracy was able to be confirmed.The delivery accuracy tests found the pump to be over delivering outside the published specification of +/-6%.The pump's expulsor will be replaced in order to bring the delivery into more nominal of a range.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.
 
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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 lane north
minneapolis MN 55442
MDR Report Key8340635
MDR Text Key136255660
Report Number3012307300-2019-00604
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10610586019449
UDI-Public10610586019449
Combination Product (y/n)N
PMA/PMN Number
K982839
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6300
Device Catalogue Number21-6300-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Date Manufacturer Received04/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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