MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-PRIZM VIP SYSTEM; PUMP, INFUSION, PCA

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.

• 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 Key: 7935805
• MDR Text Key: 122721851
• Report Number: 3012307300-2018-03944
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 6101
• Device Catalogue Number: 21-8821-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1