MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB004

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802)

Event Date 09/15/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

Event Description

Fill volume: 550 ml, flow rate: 4-14 ml/hr, procedure: total shoulder replacement, cathplace: interscalene block.It was initially reported that a patient who had total shoulder surgery on tuesday, (b)(6) 2016, passed away last night.A cb004 pump and quikbloc catheter had been used on this patient.It was reported that the patient made it through a ct scan before dying, and it was inconclusive.Additional information received on 20sep2016 stated that the female patient was in her 60s, and underwent a total shoulder replacement surgery on tuesday (b)(6) 2016.However, the surgery and interscalene block were uneventful.The patient was recovering in the hospital.The on-q pump was started initially at 4ml/h and the patient had been titrating th flow up and down between 4ml to 14ml as needed during her hospital stay.On thursday afternoon of (b)(6) 2016, the patient was feeling uncomfortable so the pump flow rate was dialed up to 14ml/h.At around 4:15pm, the certified register nurse anesthetist received a consult call from the hospital because the patient was having shortness of breath and labored breathing.The certified register nurse anesthetist arrived at the hospital at 4:45pm.At that time, the patient was having a ct scan.At the same time, a nursing was bagging the patient.Intubation was the suggestion.However, the patient's family stated that the patient's wish was "do not resuscitate." the patient was then transferred to the intensive care unit after the ct scan and chest x-ray.While in the intensive care unit, the heart monitor revealed that the patient had bradycardia and eventually asystole.The ct scan was negative, and the chest x-ray showed an elevated right diaphragm.Additional information received on 22-sep-2016 from the reporter stated that the patient was (b)(6) and weighed about (b)(6).The patient had no history of respiratory issue prior to or during her hospital stay.Her recovery was noted to be uneventful up until the event occurred.The patient was able to get out of bed and walk and take part in physical therapy.When the patient was pronounce dead, no cause could be determined.The cb004 pump was used along with a quik bloc 16g 3 inch catheter.The pump was filled to 550ml of 0.2% ropivacaine.On the third day after the surgery ((b)(6) 2016), the pump was about the size of a lime, and had been set on 6-8ml most of the time.The patient used it at 14ml/h for about 405 hours on wednesday, the second day after the surgery.Additional information received on 23-sep-2016 from the reporter stated that the pump was started around noon on the surgery date.

• Brand Name: SURGPN,400X2-14,CB SAF,-,OQ,5
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6018787
• MDR Text Key: 57057821
• Report Number: 2026095-2016-00161
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/16/2016

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: Health Professional
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: UNKNOWN
• Other Device ID Number: 10680651134728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 0.2% ROPIVACAINE; QUIK BLOC 16G 3 INCH CATHETER
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 102