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

Model Number 6101

Device Problems Occlusion Within Device (1423); Component Missing (2306); Infusion or Flow Problem (2964)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

One a smiths medical cadd-prizm® vip system was returned for analysis in good condition.Multiple "high pressure" messages were found in the device history log.The pump was visually inspected and tested for signs of function and pressure failure.The complaint was verified; pump failed occlusion test which was noted to be out of specification.Fluid ingression was noted visibly in the pumps downstream occlusion seal.The battery door to the pump was also reported missing during visual inspection.Based on the evidence, the cause of the complaint was fluid ingression.The root cause was reported to fluid ingression which is a result of user error; use of the device in a manner that is inconsistent with the instructions for use (ifu).The downstream occlusion sensor was replaced and no corrective actions were taken.

Event Description

Information was received indicating that the door to a smiths medical cadd-prizm® vip system was missing.It was also reported that there was a downstream alarm problem; failing psi test.There were no reported adverse effects.

• 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 n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7327782
• MDR Text Key: 102017148
• Report Number: 3012307300-2018-00546
• 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: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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: 01/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1