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

Model Number 2110

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Information was received indicating that this ambulatory infusion pump exhibited over delivery.No adverse patient effects were reported.

Manufacturer Narrative

Evaluation results: one cadd-solis hpca pump was returned for investigation in good condition.There was no observable damage on the pump.The pump was visually inspected and was tested for any signs of function and pressure failure.The customer's concern regarding the pump's failed accuracy was unable to be confirmed.Delivery accuracy testing found the pumps average delivery error to be within the published specification of +/-6%.

Event Description

Information was received indicating that this ambulatory infusion pump exhibited over delivery.No adverse patient effects were reported.It was further reported that there was no patient involved in this event.The customer discovered the issue while performing preventative maintenance.

• Brand Name: CADD® CADD®-SOLIS HPCA AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8061488
• MDR Text Key: 126998939
• Report Number: 3012307300-2018-08261
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1