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

Model Number 6500

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Fatigue (1849); Overdose (1988); Dizziness (2194); Pallor (2468)

Event Date 02/06/2018

Event Type  Injury  

Event Description

Information was received indicating that over infusion occurred to a smiths medical cadd-legacy® plus pump.Reported complaints of dizziness and pallor in color with no noted pump issues at that time.Later that day, the "no volume" alarm occurred to the smiths medical device and the cassette appeared to be empty.The pump rate was noted to be set to 2.9ml/hr.Subsequently, the patient was taken to the emergency department for dizziness, flushed and fatigue.The pump was changed out and the patient was admitted to the hospital.The patient recovered overnight and was discharged home the following day.No further adverse effects were reported.

Manufacturer Narrative

One cadd® cadd-legacy plus pump was returned for analysis.The customer's reported problem was "over infusion".Visual inspection showed damage on the spring in the latch lock area.The latch lock spring was replaced.The device history record (dhr) was reviewed and found to be in compliance.No manufacturing or testing issues were found in the dhr.

• Brand Name: CADD-LEGACY® PLUS PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7313781
• MDR Text Key: 101512339
• Report Number: 3012307300-2018-00479
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586019647
• UDI-Public: 10610586019647
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K982836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 11 YR
• Patient Weight: 48