MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7106-24

Device Problem False Alarm (1013)

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

Event Date 10/21/2022

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 required.

Event Description

It was reported that during the use of an extension tube, a high pressure alarm went off.Immediately after the patient started performing a priming, the alarm was issued.The patient changed the pump to another one, but the alarm persisted.The extension tube was then changed to another one and after that the system (the pump and the tube) got back working normally.So the patient suspected there was an anomaly in the extension tube.There was no patient injury.

Manufacturer Narrative

Other, other text: h6: h10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found an occlusion between the tube and filter.Functional testing found the alarm was activated, so the reported failure mode is confirmed.The root cause of the reported issue was found to be manufacturing.Excess of solvent in one of the bonding unions (luer - tubing union / tubing ? filter union) generate occluded tube.Awareness notification was generated to explain the importance to follow up correctly the bonding process documented in procedure ? completed by the quality engineer on (b)(6) 2023.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD EXTENSION SET
• 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: 15774726
• MDR Text Key: 307514038
• Report Number: 3012307300-2022-27015
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974013
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 4220039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female