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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 Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 was verified.Event log shows high pressure alarm messages.Service replaced the downstream occlusion sensor.The problem source customer induced.
 
Event Description
Information was received that the cadd prizm vip pump has high pressure alarm during infusion.No reported adverse effects.
 
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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
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
1265 grey fox road
st. paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7931549
MDR Text Key122547643
Report Number3012307300-2018-04146
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
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 Manufacturer09/10/2018
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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