MAUDE Adverse Event Report: ST PAUL CADD LEGACY PLUS PUMP; PUMP, INFUSION

Model Number 6500

Device Problems Labelling, Instructions for Use or Training Problem (1318); No Flow (2991)

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

Event Date 03/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: product complaint analyst.

Event Description

Information was received indicating that a smiths medical cadd legacy plus pump seemed to run normally, but it was not infusing medication as evidenced by a full bag 24 hours after the infusion started.The patient reported that when he initially started infusion, the pump ran as usual, made the normal sounds and the residual volume decreased to zero and when he went back to the hospital for removal, the bag was completely full as if none had been infused.The patient was given a different pump and he noticed that the medication was not infusing.He also noticed several air bubbles in the tubing between him and the pump, none of which ever moved.The air detector was off and so was the upstream sensor.There were no occlusions in the tubing between the pump and the medication bag.The label on the medication bag did not match the pump's program.The label says 5fu rate 2.2 ml/hr over 46 hours.The patient did mention that the nurse said something about speeding the infusion up to get him finished by 10am sunday.At this rate, the pump would alarm empty in 5 hours.Due to full bag and discrepancies in label and program, the pump stopped.The patient has flushes at home to flush his picc line and disconnected the pump.There was no patient harm.

• Brand Name: CADD LEGACY PLUS PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11619838
• MDR Text Key: 243962512
• Report Number: 3012307300-2021-02868
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019647
• UDI-Public: 10610586019647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2021

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: No Information
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1