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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 Excess Flow or Over-Infusion (1311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2018
Event Type  malfunction  
Manufacturer Narrative
One cadd pump was returned for analysis.Visual inspection performed and product found to be in good condition.Customer's complaint of overinfusion was not verified.Event log shows no alarms.Service did not replaced any items.Delivery accuracy testing passed.Use testing was performed.The problem source is unknown.
 
Event Description
Information was received that the cadd prizm vip pump over infused.No reported adverse effects.
 
Manufacturer Narrative
Additional information received.Event date updated.
 
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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 Key7931539
MDR Text Key122547810
Report Number3012307300-2018-03933
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 11/09/2018
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 Manufacturer08/31/2018
Initial Date Manufacturer Received 09/05/2018
Initial Date FDA Received10/03/2018
Supplement Dates Manufacturer Received08/29/2018
Supplement Dates FDA Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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