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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-PRIZM VIP SYSTEM; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. CADD-PRIZM VIP SYSTEM; PUMP, INFUSION, PCA Back to Search Results
Model Number 6101
Device Problem Inaccurate Delivery (2339)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 09/12/2018
Event Type  malfunction  
Manufacturer Narrative
One cadd prizm pump was returned for analysis.Visual inspection performed and product found to be in good condition.Customer's complaint was not verified.The event log has no evidence of the reported issue.Service performed delivery accuracy testing and found it to be within specification.Use testing was performed.The problem source is unknown.
 
Event Description
Information was received that the cadd prizm vip pump overinfused 21.628, 21.585.No reported adverse effects.
 
Manufacturer Narrative
Additional information received that this event occurred during testing and there was no patient involvement.
 
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Brand Name
CADD-PRIZM VIP SYSTEM
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8021614
MDR Text Key125614341
Report Number3012307300-2018-08013
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
PMA/PMN Number
K000842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/08/2019
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 No Information
Device Model Number6101
Device Catalogue Number21-8821-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2018
Initial Date Manufacturer Received 10/01/2018
Initial Date FDA Received10/30/2018
Supplement Dates Manufacturer Received12/13/2018
Supplement Dates FDA Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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