MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-LEGACY® PCA PUMP; PUMP, INFUSION, PCA

Model Number 6400

Device Problem Occlusion Within Device (1423)

Patient Problem Underdose (2542)

Event Date 01/04/2018

Event Type  malfunction  

Event Description

Information was received indicating that the high pressure alarm occurred to a smiths medical cadd-legacy® pca pump.The tubing was changed out and the pump continued to alarm "high pressure." the patient reported going to the hospital to have the intravenous site checked due to inability to administer medication.There were no reported adverse patient effects.

Manufacturer Narrative

One smiths medical cadd-legacy® pca pump was returned for analysis in good condition.Error 1871 was found in the device history log.The pump was later powered up and pump displayed lec 1871.The pump was opened and inspected.Visual inspection found debris in the motor gear of the pump.The debris in the gear prevented the gear from rotating resulting in 1871 error (motor - timeout).Continued inspection found that the ribbon connector lock tab broken off of the dso connector.The broken tab fell into the gear causing error 1871.The reported complaint regarding pump was alarming high pressure was unable to be duplicated.Based on these investigation results, the root cause of this issue is a service and repair error.

• Brand Name: CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7313551
• MDR Text Key: 101505868
• Report Number: 3012307300-2018-00478
• Device Sequence Number: 1
• Product Code: MEA
• 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: consumer,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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 Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: MW5074688
• Patient Sequence Number: 1