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

Model Number 6300

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the device gave error code 1340.Patient involvement is unknown.Request for more information resulted in the customer reporting "they don't recognize the serial number of the device.They cannot provide any other additional information.".

Manufacturer Narrative

Phone number: +(b)(6) b3: date of event is unknown, no information has been provided to date.Device evaluation: visual inspection found the tamper labels are undamaged and the front housing was damaged (upper right edge).Functional testing confirmed the complaint.Investigation found the device is alarming lec 1340 which is an issue with clock battery or the mainboard.Exact root cause could not be established.The service history review identified there was no indication that the complaint was related to a service of the device within the review period as the device has not been serviced in the past 12 months.The error code will be deleted.The customer will receive a cost estimate, if the estimate is accepted, the device will be repaired.

• Brand Name: CADD LEGACY PCA, GERMAN MODEL
• 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: 19084725
• MDR Text Key: 340455536
• Report Number: 3012307300-2024-02380
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• 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: 21-6300-03
• 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: 05/01/2009
• 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