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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 10036.No reported adverse effects.
 
Manufacturer Narrative
Additional information received on 31 january 2019 that there was no patient involvement during event.Device evaluation summary: one cadd prizm vip pump was returned for analysis in used condition.Visual inspection of the pump found no physical damage to the pump.The reported event was found in device event log.061> error detected 10036 16:50 (b)(6) 2018 functional testing included use testing.The pump was powered up and no error code was observed.The customer reported event could not be duplicated.Based on the history log 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 Key8192513
MDR Text Key131309971
Report Number3012307300-2018-08872
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 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
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 Manufacturer11/27/2018
Date Manufacturer Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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