MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD DUODOPA PUMPS - 1400; PUMP, INFUSION, ENTERAL

Model Number 1400

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Electric Shock (2554)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

Information was received indicating that this cadd duodopa gave mild shocks to the patient 3 times.It was reported that the patient was perspiring which got behind the battery door.It was reported then the battery door came off and the patient got mild shocks once near his heart, once by kidney and once by his right chest.

Manufacturer Narrative

Device evaluation: one smiths medical cadd duodopa pump was returned for analysis with an intact keypad and a missing top rear label.Visual inspection found evidence of fluid ingression inside the pump.During analysis, there was no evidence found to suggest the stated electrical event was caused from an intrinsic defect in the product.Verification testing was unable to reproduce any shocks from the pump during the investigation.The customer's reported problem regarding "alarming error 1660 code" was able to be duplicated, event log review confirmed that the event occurred.Power up of the pump displayed lec 1660.Simulated use was able to download event log and power up the pump to read out the pump error log.The 1660 error did not reoccur while testing the pump during investigation.However, the event log verifies that the event occurred (two 1660 alarms have been recorded in the log).Service will replace the microprocessor board to address the reported issue, due to fluid ingression and error 1660.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event was noted to be user interface.

• Brand Name: CADD DUODOPA PUMPS - 1400
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8359018
• MDR Text Key: 136785998
• Report Number: 3012307300-2019-00667
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• 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: 06/11/2019
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR