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

Model Number	21-7061-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation, including root cause analysis, is in progress.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 an error message and alarm go off.No patient injury was reported.Additional information was received via email by the manufacturer on 08-dec-2022 and attached to complaint object.A cassette was connected to an extension hose.The cassette was filled with morphine, ketamine, midazolam and sodium chloride.The cassette was filled at the users side (b)(6) 2022 and the palliative team should connect the cassette to the pump on (b)(6) 2022.By connecting the cassette to the pump, errors and an alarm accrued.The cassette was tried to be connected to other pumps, but with the same result.Eventually the pump was started, but with so many alarms, that they had to fill a new cassette the next day with a new batch instead and this batch worked normally.There was no patient involvement.
Additional Manufacturer Narrative
While performing a review of additional information provided by the customer, there was no patient involvement, therefore, no patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.File (b)(6) is no longer considered reportable, please disregard any reports associated with it.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRAION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16069539
• Report Number: 3012307300-2022-28269
• Device Sequence Number: 12320611
• Product Code: FPA
• UDI-Device Identifier: 10610586020445
• UDI-Public: 10610586020445
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: Health Professional
• Device Model Number: 21-7061-24
• Device Catalogue Number: 21-7061-24
• Device Lot Number: 4268041
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2022
• 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