MAUDE Adverse Event Report: ONQ PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Paralysis (1997)

Event Date 08/13/2020

Event Type  Injury  

Event Description

Patient admitted with shortness of breath since nerve block (on-q) placed in neck for rotator cuff surgery.Patient had a right brachial plexus block with an onq pump placed at outside facility and presented to inpatient hospital diagnosed with right hemidiaphragm paralysis.Pump was discontinued and symptoms resolved.Fda safety report id# (b)(4).

• Brand Name: ONQ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• MDR Report Key: 10436839
• MDR Text Key: 204191013
• Report Number: MW5096184
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention