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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 2120
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).One cadd solis vip pump was returned for analysis.Visual inspection performed and product found to be in good condition.Customer's complaint was verified.The event log did show error 45154.Residual fluid was found on the board, the latch/lock assembly and the flex circuit.The main circuit board.Latch/lock assembly and latch/lock flex circuit will be replaced as preventative measures.Use testing was performed.The problem source is the customer.
 
Event Description
Information was received that the cadd prizm vip pump has error 45154.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.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7915823
MDR Text Key121934768
Report Number3012307300-2018-03775
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10610586042829
UDI-Public10610586042829
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 09/27/2018
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 Number2120
Device Catalogue Number21-2120-0102-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2018
Initial Date Manufacturer Received 09/06/2018
Initial Date FDA Received09/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2016
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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