MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. CADD-LEGACY® 1400 PUMP; PUMP, INFUSION, ENTERAL

Model Number 1400

Device Problems Difficult to Flush (1251); Loose or Intermittent Connection (1371); Device Handling Problem (3265)

Patient Problem Abdominal Pain (1685)

Event Date 09/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient dropped a cadd-legacy® 1400 pump twice during the night, after which the patient had issues with a connector on the pump.Clinical support performed a home visit and met resistance trying to flush the tubing.At the same time, the patient experienced stabbing pains in the abdomen.The nurse tried to connect the pump again but a high pressure alarm went off.The reporter indicates the patient was treated with "emergency medication".No other adverse health outcomes were reported at this time.

• Brand Name: CADD-LEGACY® 1400 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 gray fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6913482
• MDR Text Key: 88119426
• Report Number: 3012307300-2017-02152
• 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,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARBIDOPA; LEVODOPA
• Patient Outcome(s): Required Intervention