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

Model Number 21-7324-01

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)

Patient Problem Pain (1994)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported that there was an incident with a pump with epidural.The fentanyl dose was a100 milliliter bag.The pump displayed a message that the bag was almost empty while there was still a remaining volume of approximately 70 milliliters minimum.A biomedical engineering technician believes the problem is with the tubing and it's caused by green anti-leakage clamp.The tubing pinches here and creates an occlusion that cannot be detected by the device.To solve the problem, you have to massage tubing while pressing anti-flow clamp to undo crushing creating obstruction.It was also indicated that they have another pump with the same problem.There was no patient injury reported but the patient had a lot of pain due to not receiving prescribed dose.No medical or surgical intervention was reported.

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 required.D5 is unknown.No information has been provided to date.

Manufacturer Narrative

H4: device manufacturing date and d4: device expiration date are unknown d4: device serial number/lot number is unknown h6: health effect and evaluation codes: updated h10: no lot number was provided; therefore, device history record review could not be performed.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms#//(b)(4).

• Brand Name: CADD ADMINISTRATION SET 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; minneapolis, MN 55442
• MDR Report Key: 15874644
• MDR Text Key: 307801944
• Report Number: 3012307300-2022-27519
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: 10610586029653
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7324-01
• Device Catalogue Number: 21-7324-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• 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