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

Model Number 21-7052-24

Device Problems Device Alarm System (1012); Failure to Deliver (2338); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Other text: no lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, the reported complaint could not be confirmed and the root cause could not be determined.If the product is returned, this complaint will be reopened for further investigation.

Event Description

It was reported that there were creases in the tubing and the pump was alarming because no drug was getting from the cassette to the pump and through the line.The patient was delayed slightly in replacing their medication cassette as they had to waste a significant amount of cassettes and lines trying to find one that worked.The patient did not go without treatment for very long.No patient injury reported.

• Brand Name: CADD EXTENSION SET WITH MICROBORE TUBING
• 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: 16673705
• MDR Text Key: 312608951
• Report Number: 3012307300-2023-03485
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974013
• 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
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1