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

Model Number 6300

Device Problems Device Alarm System (1012); Mechanical Problem (1384)

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

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the affected device was received for evaluation and visual inspection was performed.The labels were undamaged, the tamper seal was missing, and the housing was damaged.Functional testing was performed, as well as an internal inspection.The customer's indicated failure was confirmed, as the device showed error code 1870.There was a disconnected cable at the optical switch.As a result, the optical switch will be replaced, along with the rear housing.The root cause for the issue could not be determined.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 the device exhibited 'lec1870' and 'housing'.There was no patient involvement.

• Brand Name: CADD LEGACY 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19088040
• MDR Text Key: 339921280
• Report Number: 3012307300-2024-02401
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

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: 21-6300-13
• 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: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2018
• 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