MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Device Alarm System (1012)

Patient Problem Anxiety (2328)

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device had a no disposable alarm.Patient was stressed due to the delay in the delivery of treatment.

Manufacturer Narrative

H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found no damage, kinks or other defects were found.Functional testing performed based on the no disposable alarm investigation and root cause conduct trough capa-000814 the mohawk exposure could be a factor during the use of cassette to activate the alarm.However, the failure mode could not be duplicated by functional testing and no mohawk exposure detected, complaint is not confirmed.Device passed all functional testing.No problem found.No actions taken, however as part of in process controls add based on capa opened on 09/sep/2021 for no disposable alarm issue, root cause the following containment action was implemented: work instructions updated from revision 104 to revision 105 to add the mohawk exposure criteria.Complete on 08/sep/2022.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 10 avenue aristide briand; minneapolis, MN 55442
• MDR Report Key: 15454678
• MDR Text Key: 306164663
• Report Number: 3012307300-2022-19721
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4235232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female