MAUDE Adverse Event Report: ST PAUL CADD

Model Number 21-2111-0300-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information was received indicating that cadd solis hpca pump's volume measure was out of calibration.There was no patient involved.

Manufacturer Narrative

One cadd solis hpca pump was returned for analysis in good condition.No evidence of fault exists upon review of the event history log.Accuracy testing was performed; fault not duplicated.Based on the evidence, there was no fault found as the complaint was not confirmed.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 9994255
• MDR Text Key: 188803317
• Report Number: 3012307300-2020-03225
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1