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

Model Number 21-7047-24

Device Problem Inaccurate Delivery (2339)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

Other, 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 over delivered.The bag was completely empty, but the facility confirmed that the pump still read 82ml left to infuse.Length of infusion 46 hours.No patient injury reported.

Manufacturer Narrative

D10, h3, h6 - updated.One device was received for investigation.Sample received had unknown liquid remains in the fluid path, no damage or defects are observed in the sample that could contribute to failure mode reported.The device could not be functionally tested due to the remaining liquid, thus the failure mode cannot be confirmed.Root cause cannot be determined.No action will be taken.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: CADD EXTENSION SETS
• 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: 16808641
• MDR Text Key: 313938510
• Report Number: 3012307300-2023-04500
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020315
• UDI-Public: 10610586020315
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K942046
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2022
• Device Model Number: 21-7047-24
• Device Catalogue Number: 21-7047-24
• Device Lot Number: 4354701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1