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

Model Number	6500
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the a high pressure alarm went off.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device in good condition.Error was found in the device ehl (event history log) multiple times.The customer stated problem was not duplicated.No device problem was found.Preventively, replaced the downstream occlusion sensor and the upstream occlusion sensor was re-calibrated.The cause of the reported problem could not be determined.A dhr (device history 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., corrected data: d1: brand name; d2: common device name; d2: product code; d4: model number; g5: premarket (510k) number; h4: device manufacturing date.

• Brand Name: CADD LEGACY PLUS
• Common Device Name: PUMP, INFUSION
• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15051782
• Report Number: 3012307300-2022-13567
• Device Sequence Number: 20393702
• Product Code: FRN
• UDI-Device Identifier: 10610586022593
• UDI-Public: 10610586022593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• 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