MAUDE Adverse Event Report: I-FLOW ON-Q PAINBUSTER; PAIN RELIEF SYSTEM

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913); Application Program Problem: Medication Error (3198)

Patient Problems Pain (1994); Toxicity (2333); Inadequate Pain Relief (2388); Shaking/Tremors (2515)

Event Date 12/20/2013

Event Type  Injury  

Event Description

My son had bi-lateral knee surgery at (b)(6) hospital on (b)(6) 2013.Dr (b)(6) was the anesthesiologist.He explained to my wife and i that he would be using "pain balls" to control his pain after surgery.Dr (b)(6) assured us he has used these in the past and have been very successful.Our concern/complaint has been made with (b)(6) patient advocates office.I contacted them in early (b)(6).I requested a meeting with dr (b)(6) or his supervisor.As of this date no meeting has occurred.It all stems from the pain balls dispensing the medication at a rapid rate.In fact, the medication went in his system so fast the dr's told us that has never happened.Although my son had all this pain medication in his system, he was still in terrible pain.This occurred four times.Every time the pain medication went into his system as fast as the first.My wife was present the first night post-op and witnessed our son shaking violently, not from being cold or a fever.His legs hurt and she could see his body jerking.A nurse was present and tried to assist.I was present during the day.I witnessed the "deflation" of these pain balls.Again the medication went in at a furious pace.The whole time my son was in constant pain.When they finally could get the pain under control, he had 8 different iv's hooked up to him.I demanded someone get dr (b)(6) up to his floor.That's when a nurse came in from the patient advocates office.She helped the other nurses in attendance.When dr (b)(6) finally showed up he again could not understand how and why this keeps occurring.He explained to me that they (pain balls) must be defective.Plus, he wants to take my son's blood for dna testing to see if he has something in his "makeup" that would prevent the pain medication from doing its job.He advised that he would send the pain balls back to the maker/supplier to find out if a manufacturing problem existed.It wasn't until sunday the 22nd, that my son was comfortable.Dr (b)(6), told me that too much of the medication from the pain balls could be toxic.It was at this time they started to ween my son off of the pb's.I have been in contact with (b)(6) from the patient advocates office.From the very start, i explained to her that this should have never happened nor should it in the future.My understanding was dr (b)(6) was going to send those pain balls back.He left me a message in (b)(6) telling me that he didn't believe there was an issue with the pain balls.This is a lie.That was the main issue! this to me is an ethics problem.He did advise the blood testing was negative, so my son wasn't the problem, the pain balls are.Our son had so much medication in his system we can only hope nothing happens to his body as time goes on.Please help us so this never happens again to my son or any child.

• Brand Name: ON-Q PAINBUSTER
• Type of Device: PAIN RELIEF SYSTEM
• Manufacturer (Section D): I-FLOW
• MDR Report Key: 3840224
• MDR Text Key: 4411925
• Report Number: MW5036343
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 17 YR
• Patient Weight: 91