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

Model Number 6300

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported that the flow rate accuracy is unusual and irregular.There was unknown patient involvement.

Manufacturer Narrative

B3, g4, h4, d4: udi, and serial number are unknown.One device was received for evaluation.Visual inspection found no physical damage.There was no evidence of the reported problem in the device's event history log.Functional testing was conducted.Upon review, the reported problem was unable to be duplicated.The pump accuracy was within specification; however, it was near the upper limit.Preventively, the expulsor was adjusted.The service history review identified no indication that the complaint was related to a service of the device within the review period.

Manufacturer Narrative

Additional information: s/n updated to (b)(6).

• Brand Name: CADD-LEGACY PCA AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18511322
• MDR Text Key: 333261823
• Report Number: 3012307300-2024-00230
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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: Health Professional
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-09JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1