MAUDE Adverse Event Report: ST PAUL CADD-LEGACY 1400 PUMP; PUMP, INFUSION, ENTERAL

Model Number 1400

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the device was in use with patient and pump became exposed to fluid.The reporter stated the patient received 3 shocks.Smiths medical has requested additional patient information with no information received at this time.No adverse effects to patient reported.

Manufacturer Narrative

Additional information: concomitant medical products.One cadd duodopa pump was returned for analysis.No damage was observed on the pump and no evidence of fluid ingression observed.The customer's reported problem regarding a wet pump shocked the patient was unable to be duplicated.Visual inspection did not observe evidence of fluid ingression on the pump.Investigation testing of the pump did not produce any stray electrical charge or shock from the pump.The pump was investigated by verifying the pump met specification.Delivery accuracy testing on the pump found the pump to be within the published specification of +/-10%.Sensor verification found the downstream occlusion high pressure sensor within specification, but the value measured was at the top of range.The downstream occlusion will be replaced as preventative maintenance.Simulated use testing was unable to replicate the issue with a disposable attached.No problem found with the pump.No accessories or disposables used in the infusion system were returned for investigation of the shocking patient issue.

• Brand Name: CADD-LEGACY 1400 PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 8378463
• MDR Text Key: 137420196
• Report Number: 3012307300-2019-01079
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• PMA/PMN Number: N203952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1401-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1