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

Model Number 21-7302-24

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received regarding a cadd cassette reservoir.It was reported that it was impossible to operate the patient controlled analgesis, pca, with the cassette.There was no issue with the pump used.A cassette from a different lot resolved the issue.There was no patient, or clinician injury associated with this occurrence.No further details provided at this time.

Manufacturer Narrative

Other, other text: additional information h6, h10.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No problems or issues were identified during the device history record review.Six samples were received in unused conditions with its original packaging and one sample was received in used conditions without its original packaging, decontaminated and inside in plastic bag.Visual inspection was performed at 12 to 16 inches under normal conditions of illumination.The used sample received was found without blue clip and with pressure plate damaged.During the functional testing, the samples were fully primed and connected without difficulty, the pump was set running and no alarms were activated.The complaint was not confirmed.The root cause was unable to be determined.No actions taken were performed since the complaint was not confirmed.E4 was unknown, corrected data: d1.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12375505
• MDR Text Key: 268429196
• Report Number: 3012307300-2021-08891
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 4076282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1