MAUDE Adverse Event Report: ST PAUL CADD LEGACY 1 PUMP; PUMP, INFUSION

Model Number 21-6400-51

Device Problem Device Alarm System (1012)

Patient Problem Syncope/Fainting (4411)

Event Date 06/07/2021

Event Type  malfunction  

Event Description

It was reported that during use of the pump, it was alarming no disposable, pump won't run.The patient reported that she was on hold for a long time (about 45 minutes) and started to feel a little light headed so she mixed a new cassette and switched to a backup pump which resolved the problem.Per information provided, the infusion contained remodulin.No medical or surgical intervention was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter (b)(4).No problems or issues were identified during this device history review.A product sample was received for evaluation.Visual inspection revealed the tamper seals and labels were intact.Performed functional check and visual inspection of the pump.While running the pump with customer's returned program, the reported problem could not be duplicated.Root cause of the reported issue is unknown.However, it was recommended that the downstream occlusion sensor be replaced due to the no disposable alarm messages were found in the pump's event history logs after starting.

• Brand Name: CADD LEGACY 1 PUMP
• Type of Device: 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; minneapolis, MN 55442
• MDR Report Key: 16444061
• MDR Text Key: 310256443
• Report Number: 3012307300-2023-01702
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: 10610586019548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2023

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 Operator: Lay User/Patient
• Device Expiration Date: 04/05/2016
• Device Model Number: 21-6400-51
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female