MAUDE Adverse Event Report: HALYARD HEALTH, INC. ON-Q; PUMP, INFUSION, ELASTOMERIC

Lot Number PM040-A

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 12/28/2017

Event Type  Death  

Event Description

Preoperative plan was to place an on-q pump for local anesthesia.The on-q representative was present in the operating room to assist with any questions.Per the physician documentation: a 2 mm incision was made, the on-q trocar was then advanced in the subcutaneous tissue above the fascia and followed laterally and posteriorly towards the scapula by direct palpation for approximately 8 cm.After this was well positioned, the trocar was removed, leaving the sheath.There was no bleeding noted.The on-q pump tubing was then advanced through the sheath.The sheath was then withdrawn and the catheter tubing appeared to be in appropriate position and was palpated in the subcutaneous soft tissue.The catheter tubing was aspirated and there was no bleeding noted, and then 5 ml of 0.5% bupivacaine was injected into the on-q tubing with a 5 cc syringe.This appeared well tolerated.An additional 3 ml of 0.5% bupivacaine was injected into the port tubing.The on-q trocar was then advanced subcutaneously on the left and demonstrated to be subcutaneous by palpation.At this point the trocar was removed leaving the sheath after being advanced toward the scapula for approximately 8 cm.The on-q tubing was then advanced into the sheath, and the sheath was then withdrawn leaving the on-q tubing in place.At this point, the anesthesiologist reported that the patient appeared to be in arrest.Chest compressions were initiated and after 4 hours of cpr, the patient was declared deceased.

• Brand Name: ON-Q
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7291705
• MDR Text Key: 100768556
• Report Number: 7291705
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018,01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Lot Number: PM040-A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, ANESTHESIA INDUCTION AND PAIN MEDICATIONS; PATIENT WAS INTUBATED AND HAD IV ANESTHESIA INDUCT
• Patient Outcome(s): Death
• Patient Age: 15 YR
• Patient Weight: 62