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

Model Number 21-7359-24

Device Problems Failure to Deliver (2338); Inaccurate Delivery (2339); Improper Flow or Infusion (2954)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: 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 the disposable line got kinked and no drug was infused but the device never alarmed.Continuous infusion rate: 3 ml/hr reservoir volume: 150 ml pump bag (contained 138 ml of drug): length of infusion: 46 hours.No fluorouracil was given for 46 hours when it should have been running.No patient injury reported.

Manufacturer Narrative

Corrected data: h6: evaluation codes result.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.

• Brand Name: CADD ADMINISTRATION SETS - 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17037263
• MDR Text Key: 316285178
• Report Number: 3012307300-2023-05922
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: 10610586027406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2023

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
• Device Model Number: 21-7359-24
• Device Catalogue Number: 21-7359-24
• Device Lot Number: 4298369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/08/2023; 09/14/2023
• Supplement Dates FDA Received: 06/14/2023; 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1