MAUDE Adverse Event Report: ST PAUL CADD; CADD CASSETTE RESERVOIRS - FLOW STOP

Model Number 21-7302-24

Device Problem Failure to Deliver (2338)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

H6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.One sample was returned for investigation.Sample was received in used conditions without its original packaging, decontaminated and inside in a plastic bag.Visual inspection and functional test were performed.Visual inspection found no damage, kinks or any discrepancies that could cause the failure mode reported.For functional testing the sample was filled with 100 ml of water and connected to the cadd legacy plus to look for unusual function.No alarms were activated.The complaint was not confirmed.No root cause was determined as the complaint was not confirmed.No action was taken as the complaint was not confirmed.No fault was found with the device.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that a patient observed that drug infusion had been spontaneously stopped.No patient injury reported.

• Brand Name: CADD
• Type of Device: CADD CASSETTE RESERVOIRS - FLOW STOP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16692521
• MDR Text Key: 312810259
• Report Number: 3012307300-2023-03676
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4096351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1