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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 Device Displays Incorrect Message (2591)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Information was received that the cadd prizm vip pump had error code 10102.No reported adverse effects.
 
Manufacturer Narrative
Additional information received on (b)(6) 2018 indicating there was no patient involvement.Device evaluation summary: one cadd prizm pump was returned for analysis.Visual inspection of the pump showed that pump was in good condition.The pump was inspected and error code 10102 was found on display.Further investigation of the pump found that the rtc battery had a low voltage.A low voltage can cause device to have this issue.Based on the evidence, the complaint was confirmed.The root cause could not be identified.
 
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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 Key8175934
MDR Text Key130712648
Report Number3012307300-2018-08837
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 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
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 Manufacturer11/21/2018
Date Manufacturer Received12/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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