MAUDE Adverse Event Report: NULL CADD-SOLIS AMBULATORY INFUSION PUMP

Model Number 2110

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Reporter stated the device required investigation and event log examination related to "infusion inaccuracy".Reporter stated the event involved a patient but did not provide any patient information.Additional information has been requested and not received at this time.

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 event history log noted "loss of power occurred while running".Functional tests included use and accuracy testing.Delivery accuracy testing found the pumps average delivery error to be within the published specification of +/-6%.The pump was in specification during the occlusion and functional tests.Further inspection found cracks and fluid ingression on the pump's downstream sensor.The micro processor board and downstream sensor were replaced as a preventative measure.Based on the evidence, the complaint regarding infusion accuracy was unable to be confirmed.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section G): NULL
• MDR Report Key: 7954790
• MDR Text Key: 123361241
• Report Number: 3012307300-2018-04260
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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: 2110
• Device Catalogue Number: 21-2111-0100-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1