MAUDE Adverse Event Report: ST PAUL CADD; PUMP, INFUSION

Model Number 21-2111-0300-01

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that the cadd solis hpca pump had an inaccurate flow rate.There was no adverse event reported.

Manufacturer Narrative

Device evaluation: one smiths medical cadd solis hpca pump was returned for analysis with no physical damage noted on the device.During analysis, the delivery accuracy tests found the pump to be out of the published specification of +/-6%.The pump's expulsor will be replaced in order to bring the delivery into more nominal of a range.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10779792
• MDR Text Key: 214393502
• Report Number: 3012307300-2020-10940
• 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: 01/14/2021

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: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1