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

Model Number 6300

Device Problems Device Alarm System (1012); Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

H3: device not received by manufacturer.D4 - serial #: reported as either (b)(6) or (b)(6).H4: unknown.No product was returned.The investigation determined the most probable cause to be a main board failure, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

Event Description

It was reported that during use, the patient presented to the emergency department because the pump would not stay running; it kept alarming and going into stop mode.The batteries were changed but the pump continued to alarm every 10 minutes.The pump was replaced.Per the reporter, there were no adverse patient effects.

• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18727403
• MDR Text Key: 336638422
• Report Number: 3012307300-2024-00863
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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