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

Model Number	21-7381-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2023-06232
• Device Sequence Number: 6457937
• Product Code: FPA
• UDI-Device Identifier: 10610586027468
• UDI-Public: 10610586027468
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown