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

Model Number 6101

Device Problems Device Alarm System (1012); Occlusion Within Device (1423)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

One smiths medical cadd-prizm® vip ambulatory infusion pump was returned for analysis in good condition.The event history log was reviewed and noted no evidence of failing downstream occlusion.The complaint was verified following a pressure switch test.The test was found to be not activated during the investigation.Upon visual inspection of the pump, fluid ingression was noted which indicates that the occlusion sensor requiring replacement.Based on the evidence, the cause of the downstream occlusion failure was related to fluid ingression.The root cause is determined to be user error.The issue of fluid ingression is a result of use of the device in a manner that is inconsistent with the instructions for use (ifu).

Event Description

Information was received indicating that a smiths medical cadd-prizm® vip ambulatory infusion pump failed downstream occlusion test.There were no adverse effects reported.

• Brand Name: CADD-PRIZM® VIP AMBULATORY INFUSION PUMP
• 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: 7319090
• MDR Text Key: 101728634
• Report Number: 3012307300-2018-00504
• 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: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• 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: 12/29/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1