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

Model Number	21-7383-24
Medical Device Problem Codes	Device Alarm System (1012); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the disposable caused the pump to alarm low reservoir volume and stopped approximately 4.23 hours sooner than expected.No patient injury reported.
Additional Manufacturer Narrative
No further information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No product has been received for evaluation.Three (3) photos were provided by the customer which were used to conduct the device analysis since the physical unit, by the time this investigation is being documented, has not been received.Photo one shows the distal end of administration set where the check valve is observed to be disconnected from the tube; no other damage or dysfunctional conditions are observed.Photo two and three shows a pouch label for the administration set product of part number 21-7361-24 and lot 4321084; the device is not present in these photos.The reported failure mode, damaged, is confirmed.Root cause: after reviewing the mitigations that are performed during the manufacturing process to detect damage, and analyzing the photos provided, the root cause cannot be determined.Action taken: no corrective actions are required because the mitigations on place were revised and are being executed as is determined by procedure.This failure will continue to be monitored to determine if new actions need to be taken.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.If the device arrives, this complaint will be reopened for investigation.

• Brand Name: CADD ADMINISTRATION SETS - 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: 16588010
• Report Number: 3012307300-2023-02712
• Device Sequence Number: 14977262
• Product Code: FPA
• UDI-Device Identifier: 10610586027475
• UDI-Public: 10610586027475
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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
• Device Model Number: 21-7383-24
• Device Catalogue Number: 21-7383-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 71 YR
• Patient Sex: Male