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

Model Number 21-7301-24

Device Problems Device Alarm System (1012); Pressure Problem (3012)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump exhibited "constantly pressure alarm".No patient injury reported.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).No problem or issues were identified during the device history record review.A sample was received for evaluation.Sample was received in used conditions without its original packaging, decontaminated and inside in a plastic bag.During visual inspection, the sample was visually inspected at a distance under normal conditions of illumination to detect sample conditions that could cause functional issues.Samples didn?t present any damages, kinks, cuts or conditions that could cause failure mode.During pump tube height testing, the sample was tested to measure the height of the pump tube arch and determine if is under or out of specification following the procedure.The pump tube height measure failed.However, due to the samples being received in used conditions it is possible that the pump tube height was modified during the use.During accuracy testing, the samples received were connected to a pump and the and a balance mettler toledo to look for unusual function.The sample could be connected without problem and passed the delivery accuracy test.During functional testing, sample was filled with 50 ml of water; the sample was connected to the pump to look for unusual function.The sample fully primed and connected without difficultly, the pump was set running and no alarms were activated.Complaint is not confirmed.No root cause was determined due complaint was not confirmed.No action taken.

• Brand Name: CADD CASSETTE RESERVOIRS - 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; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12789301
• MDR Text Key: 280706322
• Report Number: 3012307300-2021-10978
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• UDI-Public: 10610586027215
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7301-24
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 4135505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1