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

Device Problem Defective Device (2588)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported that per mw511288 patient reported malfunctioned cassette.Patient changed cassette last night, 2022, pump started beeping.Would not stop until a different cassette was put in.Pump was fine after a new cassette used.Patient uses premix iv remodulin via cadd legacy pump.The reported product fault did occur while in use with a patient.The product issue did not cause or contribute to patient or clinical injury.The cassette is not available to be returned for investigation.Outcome of the event was resolved; lot number is unknown.The cassette was replaced, the patient did have additional cassettes they were able to switch to and was able to successfully continue their life sustaining infusion.Additional information received by smiths medical icu on (b)(6) 2022 via email and attached to complaint object no clinical injury was documented.Patient details are updated: cassette is not available for return.

Manufacturer Narrative

Udi and catalog information are unknown.Premarket (510k) number is unknown.Operator of device is unknown.No information has been provided to date.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.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.No product was received; therefore, visual and functional was not performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15756723
• MDR Text Key: 306876740
• Report Number: 3012307300-2022-26932
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female