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

Model Number 6300

Device Problem Device Alarm System (1012)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown, no information has been provided to date.Device evaluation: one device was returned for investigation.Visual inspection found no physical damage to the device.As a result of checking the error history log, it confirmed that there was a record of occurred error code 1871 during the pump priming on march 3, 2024.The complaint was confirmed.Root cause was attributed to a defective motor; which was replaced.The 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 there was an error code 1871 during prime.The fault occurred during setup in progress.There was no patient involvement and no harm/adverse event reported.

• Brand Name: CADD LEGACY AMBULATORY PCA 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: 19085013
• MDR Text Key: 339877969
• Report Number: 3012307300-2024-02386
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2024

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: Other
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-09JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2007
• 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