MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY PUMP; CADD LEGACY PUMP INFUSION ENTERAL

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2017

Event Type  malfunction  

Event Description

Pt reports that he dropped his cadd legacy pump sn (b)(4) on friday night, (b)(6) 2017.States that although there was no outward damage, the pump kept beeping and would not stop.States he removed and replaced the batteries but the pump would not run, it just kept beeping.He did not know what error code or message was on the screen and he was not around the pump to turn it on to check.He just states it will not work and he needs a new one.Pt switched to his other pump and has been using that so there was no interruption in therapy and therefore no adverse events due to this.Sending a new pump to arrive tomorrow morning; 80ng/kg/min, continuous iv, (b)(6) 2013 to present.Reason for use: pah.

• Brand Name: CADD LEGACY PUMP
• Type of Device: CADD LEGACY PUMP INFUSION ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6797085
• MDR Text Key: 82919905
• Report Number: MW5071599
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR