MAUDE Adverse Event Report: TELEFLEX MEDICAL TELEFLEX AUTOFUSER; PUMP, INFUSION, ELASTOMERIC

Device Problem Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Pain (1994); Discomfort (2330); Numbness (2415); Cough (4457); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 04/23/2023

Event Type  Injury  

Event Description

I was given a arrow teleflex auto fuser containing ropivicaine.I noticed shortness of breath which i was told was not a real symptom prior to use.It felt like my diaphragm was not moving properly.This continued for the 3 days i used the device.I finally stopped use due to the discomfort in my chest.I began heavy coughing about 2 hours after stopping.Coughing up a lot of sticky mucus.The installation of the device has also caused significant pain and muscle pain and spasm in my neck.I would never allow it's use on me again.Oxycodone or similar would have been fine and much less invasive and damaging.The medication caused numbness and pain in my hand that became serious at the "6" setting.

• Brand Name: TELEFLEX AUTOFUSER
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 16818259
• MDR Text Key: 314109760
• Report Number: MW5117069
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/24/2023

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2023
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG; B12.; BYSTOLIC.; DOXSOCIN.; PRAULENT.; PREVACID.; ROPIVACAINE
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White