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

Catalog Number 21-6300-02

Device Problem Device Alarm System (1012)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the device had ¿code error 1871¿.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3: date of event is unknown.One device was received for investigation.The device was visually inspected.During visual inspection, it was found that the device records show an error code 1871, which points to a faulty motor.Functional test couldn't be performed due to nature of the issue.The faulty motor was replaced.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• 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: 19197203
• MDR Text Key: 341308588
• Report Number: 3012307300-2024-03108
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586019357
• UDI-Public: 10610586019357
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

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 Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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