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

Model Number	21-7321-24
Medical Device Problem Codes	Inaccurate Delivery (2339); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, icu medical will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
It was reported that there are long delays in infusion to the patient when administering chemotherapy and when used for pain relief.It was noted 5 different deviations related to the use of the cassettes.Four cassettes were used for chemotherapy treatment which was significantly delayed.One cassette was used in pain management.No adverse patient effects were reported by the customer.

• Brand Name: CADD ADMINISTRATION SETS WITH FLOW STOP
• 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: 17368407
• Report Number: 3012307300-2023-07461
• Device Sequence Number: 3784531
• Product Code: FPA
• UDI-Device Identifier: 10610586029639
• UDI-Public: 10610586029639
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: Other
• Device Model Number: 21-7321-24
• Device Catalogue Number: 21-7321-24
• Device Lot Number: 4230905
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown