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

Model Number 21-7322-24

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

It was reported that the patient returned to the infusion center for pump off and it appeared only half of the infusion was complete.The pump reported all 250 ml were infused.Patient stated the pump never alarmed at home.Programming mode: continuous reservoir volume: 250 ml given: 250 ml air detector on/off: unknown upstream sensor on/off: unknown length of infusion: 46 hours.Configuration 100ml cassette, 250ml cassette.The administration set primed using gravity.Phaseal additional add-on pieces specifically cstd.There is needless connector on the end of the iv line.No adverse patient effects were reported by the customer.

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.

Manufacturer Narrative

Other, other text: additional information is provided for h.2 and h.6.No product was returned.The investigation was unable to confirm the reported complaint or determine a root cause.If the product is returned this complaint will be reopened for further investigation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.G1, email address: (b)(6).

• Brand Name: CADD ADMINISTRATION SETS 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17309812
• MDR Text Key: 319129577
• Report Number: 3012307300-2023-07152
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029646
• UDI-Public: 10610586029646
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

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: 21-7322-24
• Device Catalogue Number: 21-7322-24
• Device Lot Number: 4334319
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1