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

Model Number 2110

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported the device dso (downstream occlusion sensor) failed to calibrate.No patient injury was reported.Additional information reported no patient incident, found during testing.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms#617147.The device was returned for investigation.A visual inspection and functional test were performed.Visual inspection did found the smiths tampered seal label was missing.The customer stated problem was not confirmed and could not be duplicated.The downstream occlusion sensor was replaced as a precaution and a full standard pm was performed.The root cause could not be determined.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16699994
• MDR Text Key: 312872166
• Report Number: 3012307300-2023-03726
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1