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

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)

Patient Problems Chest Pain (1776); Insufficient Information (4580)

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

Report source: hospitalization.

Event Description

Information was received indicating that a pump with a cadd cassette reservoir was alarming and woke her up at 3:30 am with alarm "no disposable, clamp tubing".The end user reportedly attached a new cassette to the back up pump but was not sure how long she was off the therapy, so she contacted her doctor.Per reporter the doctor directed the end user to go to the hospital for evaluation, she reported having chest pain.It was also reported the end user was able to continue infusion using backup products.Medication: veletri united therapeutics, dose: 20ng.Kg.Min continuous iv.Dates of use: from 03/2021 to current.Diagnosis or reason for use: pulmonary arterial hypertension (pah).

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Additional information: b1 adverse event and/or product problem, b2 outcomes attributed to adverse event and d5 operator of device., corrected data: corrections g3 report source and h1 type of reportable event.

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13469785
• MDR Text Key: 288096925
• Report Number: 3012307300-2022-02755
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female