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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 Date 08/31/2018
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 error code 10037 was not verified.Event log shows error code 10037 after 9 volt battery depleted.Service will replace the motor as a precaution.Coin latch was replaced.Use testing was performed.The problem source is unknown.
 
Event Description
Information was received that the cadd prizm vip pump has error 10037 and latch lock is worn.No reported adverse effects.
 
Manufacturer Narrative
One pump was returned for analysis in used condition.Visual inspection of the pump showed that the pump was in good physical condition.The device event log noted error code messages were recorded.Functional tests included use testing.The pump was started up and an error code message was unable to be duplicated.The motor and stripped coin latch lock were replaced.Based on the evidence, the complaint was confirmed.The root cause was unable to be established.
 
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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 Key7935805
MDR Text Key122721851
Report Number3012307300-2018-03944
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,Followup
Report Date 11/14/2018
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 Manufacturer09/14/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/07/2018
Initial Date FDA Received10/04/2018
Supplement Dates Manufacturer Received10/15/2018
Supplement Dates FDA Received11/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2013
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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