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

Model Number 1400

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

No product was returned and were unable to confirm the reported complaint.

Event Description

Information was received indicating that a patient receiving levodopa/carbidopa via a smiths medical cadd-legacy® duodopa pump had fallen, pulling intestinal tube completely out.The patient will continued to be hospitalized and was prescribed oral medication.It was reported that the intestinal tube will be replaced.No further adverse effects were reported.

Event Description

It was additionally reported that the patient was already hospitalized for a placement of a peg tube at the time of the event.The pump falling and pulling out of the tube prolonged hospitalization.

Manufacturer Narrative

One smiths medical cadd-legacy® duodopa pump was returned for analysis showing no signs of damage.The pump was noted to pass all tests and was found operating properly.The complaint was unable to be confirmed.Based on the evidence, the device and the investigation of the issue could not confirm the root cause of the fault that occurred.

• Brand Name: CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7252497
• MDR Text Key: 99373849
• Report Number: 3012307300-2018-00210
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LEVODOPA/CARBIDOPA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR