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

Event Description

It was reported that during infusion, the device exhibited a frequent cassette disconnected alarm.There was no patient harm reported.

Manufacturer Narrative

B3: event date unknown.One device was returned for evaluation.Visual inspection revealed no physical damage.The event history log confirmed a record of repeated power on/off on, presumably caused by a beep sound as an alarm before the nda was finalized.Functional testing was able to replicate the reported issue.The root cause was determined to be a defective downstream sensor.The downstream sensor was replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• 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: 19163204
• MDR Text Key: 341365726
• Report Number: 3012307300-2024-02920
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/22/2024

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: 21-6300-09JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• 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