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

Model Number 21-7302-24

Device Problem Inaccurate Delivery (2339)

Patient Problems Fatigue (1849); Dizziness (2194)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

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 during the use of the product, an under delivery of medical fluid was observed.When the patient used a cassette there was an under delivery of medical fluid was observed.More than 30 ml remained in the cassette while 20 ml or less was supposed to be in it.The part where the medication bag and the tubing were adhered looked narrower than normal.The patient complained of the symptoms such as difficulty in breathing, fatigue, lightheadedness when standing up, and rapid pulse.

Manufacturer Narrative

Device evaluation: ten samples were received in new condition.No damage was found during a visual inspection.During the functional testing, the pump tube height measure passed the test and the samples could be connected without problem during the accuracy test.The customer reported complaint was not confirmed.A root cause was not confirmed.There was no non-conformance or deviation related to the failure reported in the device history record for finish good and component associated.By the date of this complaint investigation report no more complaints related to the failure mode and lot number reported in the last 12 months.

• Brand Name: CADD ADMINISTRATION SETS 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17031856
• MDR Text Key: 316252149
• Report Number: 3012307300-2023-05907
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• 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: 4349145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1