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

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2022

Event Type  Injury  

Event Description

It was reported that a patient has experienced a run of issues with cassettes relating to pump alarms for intermittent upstream occlusions.Elimination efforts related to specific (3) pumps were negative, at least one pump was sent to the agent for technical review, no fault found.A new lot number of sets were supplied by the company and no further issues were experienced.Additional information was provided that there was medical intervention and the event resolved.Inpatient treatment was required to ensure therapy continued uninterrupted due to pump alarm and not infusing.The patient has a dependent condition that interrupted therapy cannot be tolerated.

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.

Manufacturer Narrative

H3: device evaluated by manufacturer: updated.H6: event problem and evaluation codes: updated.D10: device available for evaluation: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.Visual inspection found no damage or kinks or any discrepancies that could cause the failure mode reported.The reported problem was not duplicated.The sample was fully priming and connected without difficulty, the pump was set running and no alarms were activated.Functional testing successfully passed, and the failure mode reported was not confirmed / not duplicated.No root cause was determined as the complaint was not confirmed.No corrective actions were taken as the complaint was not confirmed.A dhr (device history review) was performed, and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.This remediation mdr was generated under protocol (b)(4), 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: 15945739
• MDR Text Key: 305138815
• Report Number: 3012307300-2022-27800
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• 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: 4235232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• 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 Outcome(s): Required Intervention