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

Catalog Number 21-1401-01

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One infusion pump was returned for evaluation.Visual inspection of the pump found it to be missing the upper back label and has noted to have fluid ingression; no cracks observed.Device then underwent functional testing; customer complaint unable to be confirmed.However, pump's event history log did show "high pressure" alarm messages after extra dose completed and key stuck message.Three separate delivery accuracy tests found the pump r to be delivering within the published specification of +/-6 percent.It is unknown what caused the reported complaint, and while no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

Event Description

Information was received that a smiths medical cadd legacy infusion pump is having an issue.It was reported that extra doses are being used.No patient injury reported.

• Brand Name: SMITHS MEDICAL CADD-LEGACY DUODOPA AMBULATORY PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9536132
• MDR Text Key: 177400822
• Report Number: 3012307300-2019-07323
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N203952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-1401-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1