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

Model Number 6101

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670)

Patient Problem Overdose (1988)

Event Date 11/04/2017

Event Type  Injury  

Event Description

Information was received indicating that the patient with this ambulatory pump received too high of a demand dose.The patient required narcan due to the over delivery of medication.No additional adverse patient effects were reported.

Manufacturer Narrative

One device was returned for evaluation.Visual inspection found the device in good condition with the labels intact.It was observed that there was damage to the input/output data input, with broken remote dose cable connector pins jammed into the socket, and a crack in the front housing.It was observed that there was fluid ingression on the downstream occlusion and upstream occlusion sensors.Delivery accuracy tests were performed and the reported issue was unable to be duplicated, and all accuracy was within manufacturing specifications.It was suspected that a possible cause of the reported issue was due to fluid ingression to the expulsor gasket.Based on the evidence, a root cause was unable to confirmed.

• Brand Name: CADD-PRIZM® PCS II 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.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7052399
• MDR Text Key: 92740447
• Report Number: 3012307300-2017-02478
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6101
• Device Catalogue Number: 21-8851-01D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention