MAUDE Adverse Event Report: ST PAUL CADD HIGH VOLUME ADMINISTRATION SETS WITH FLOWSTOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7381-24

Device Problem Inaccurate Delivery (2339)

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

Event Type  malfunction  

Manufacturer Narrative

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 the customer had several complaints from patients about their infusion bags running out before the scheduled times and that the problem may be with the tubing.The cassette delivered 54 ml after programming for 50 ml.These did not meet a +/-6% threshold.All were tested with the same pump, which when sent in for preventative maintenance, was certified without issue.

Manufacturer Narrative

No product was returned.The reported complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.If the product is returned this complaint will be reopened for further investigation.G1, email address: (b)(4).

• Brand Name: CADD HIGH VOLUME ADMINISTRATION SETS WITH FLOWSTOP
• 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: 17127467
• MDR Text Key: 317216527
• Report Number: 3012307300-2023-06232
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027468
• UDI-Public: 10610586027468
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7381-24
• Device Catalogue Number: 21-7381-24
• Device Lot Number: 4257088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1