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

Model Number 21-7302-24

Device Problem Protective Measures Problem (3015)

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

Event Date 06/24/2022

Event Type  malfunction  

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 additional reportable information becomes available.

Event Description

It was reported that during the pre-use check, a no message alarm went off.No patient injury was reported.

Manufacturer Narrative

H10: device evaluation: one sample was returned for investigation.The sample consisted of one cassette product; the sample was received after used conditions, without its original packaging, decontaminated and inside in a plastic bag.The sample was visually inspected under normal conditions of illumination to detect conditions that could cause functional issues.No damage was detected in the sample that could cause the failure mode reported.The sample was connected to a cadd pump to look for unusual functions; no alarms were activated.This testing was repeated a second time; no alarms were activated.Based on the no disposable alarm investigation and root cause conduct through capa-000814 the mohawk exposure could be a factor during the use of cassette to activate the alarm.However, the failure mode could not be duplicated by functional testing; the complaint was not confirmed.No fault was found and as such, no root cause was determined, and no corrective actions taken; however, capa-000814 was open to investigate the failure mode reported; capa-000814 is currently in solution confirmation and implementation plan phase.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).No lot/serial number was provided, therefore the product manufacture or expiration date was unknown.

• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15045631
• MDR Text Key: 303669017
• Report Number: 3012307300-2022-13532
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Male