MAUDE Adverse Event Report: ST PAUL CADD-LEGACY PLUS PUMP; PUMP, INFUSION

Model Number	6300
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
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.Premarket (510k) number is unknown.
Event or Problem Description
It was reported that the pump stopped and medical fluid was unable to be infused to the patient.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: the device was returned to smiths/icu medical.No physical damaged was found on the device.The event history log confirmed that a no disposable alarm occurred during pump operation on june 7, 2022, causing the pump to stop, followed by a record of repeated power on/off cycles that could be due to a cassette connection recognition failure.The reported issue was not duplicated during functional testing.The downstream sensor was replaced, and the upstream sensor was re-calibrated as preventive maintenance.A dhr review was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.The device manufacturer date was not documented in the initial report.The model number and premarket (510k) number were not documented, in the initial report.The report source has been recategorized.

• Brand Name: CADD-LEGACY PLUS PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14746282
• Report Number: 3012307300-2022-12230
• Device Sequence Number: 6637441
• Product Code: FRN
• UDI-Device Identifier: 10610586022593
• UDI-Public: 10610586022593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 6300
• Device Catalogue Number: 21-6300-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2015
• 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