MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,600X1-7D,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB6007

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

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

Event Date 08/12/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Udi # unknown.Method: the actual device was not returned.A review of the device history record (dhr) was not performed as no lot number was provided.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.Per the instructions for use (ifu) there are several factors that may affect the flow rate including fill volume, temperature, viscosity of the drug solution, pump position, storage time and external pressure.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).Device not returned.

Event Description

A report was received by a clinical specialist stating that a patient who underwent coronary artery bypass graft surgery coded in the intensive care unit about two hours after the surgery.The patient did not survive.The doctor was performing the coronary artery bypass graft on a male patient.After he closed the patient's midline chest incision, he placed two 7 1/2 inch catheters on each side of the patent's sternum.A device was attached to the two catheters with the dials set at 6 ml/h.The surgery was complete.The patient was moved from the cardiovascular operating room to the intensive care unit around 2:30 pm to 3:00 pm uneventfully.The patient coded between 3pm and 5:30pm.Additional information received on 08/23/2016 from the sales rep stated that the device and two 7 1/2 inch silversoaker catheters were used on the patient.The catheters were placed bilaterally parallel to the sternum.The pump fill volume was not noted on the patient's file.The cause of death is noted as cardiac arrest.The reason for the cardiac arrest and time of death was not noted on the patient's record.The resuscitation record was not on his file.It is unknown if the patient was accepted for autopsy.Additional information received on 08/24/2016 from the director of the hospital's cardiovascular operating room stated that the sample was discarded.No sample will be returned.

• Brand Name: SURGPN,600X1-7D,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: 5939125
• MDR Text Key: 54303841
• Report Number: 2026095-2016-00140
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: CB6007
• Device Catalogue Number: 101347700
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.2% ROPIVACAINE
• Patient Outcome(s): Death
• Patient Age: 48 YR
• Patient Weight: 45