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

Model Number CB6007

Device Problem Infusion or Flow Problem (2964)

Patient Problems Tinnitus (2103); Toxicity (2333); Numbness (2415); Confusion/ Disorientation (2553)

Event Date 09/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record for the reported lot is in-progress.Upon completion of the investigation, a follow-up report will be filed.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: 750 ml, flow rate: unknown ml/hr, procedure: cardiac surgery, pump start time: unknown time on (b)(6) 2016, pump end time: unknown time on (b)(6) 2016.It was reported that a pump showed local toxicity on a patient with symptoms in the form of ringing in the ear, a metallic taste in the mouth, confusion, and peri-oral numbness.The symptoms occurred greater than 48 hours into the infusion.The patient was reported as fine and being disconnected from the pump.An anesthesiologist believed the patient was laying on the ball.

Manufacturer Narrative

The pump was returned empty.The distal luer on line #1 appeared to be missing due to damage.A new luer was added with cyclohexanone.A baxa repeater pump was used to refill the pump with 600ml of 0.9% saline.The pinch clamps were opened and the (select-a-flow) safs infused at all selectable flow rates.Flow accuracy testing was performed on the pump with each saf set to 6ml/hr.After 65 hours of testing, the pump yielded a flow rate on saf #1 of 3.20ml/hr and on saf #2 of 3.19 for a combined rate of 6.39ml/hr which is within specification with a with a +/- 20% tolerance.Pressure pot testing was performed on the selected-a-flow unit flow rates 1ml/hr, 2ml/hr, 4ml/hr and 7ml/hr without the filter.The saf units were detached from the pump.The saf units were connected to a pressure gauge.The average bladder pressure used was 7.13psi.The saf #1 flow 1ml/hr did not flow.The 1ml/hr flow on saf #2 yielded a rate of 1.11ml/hr, which is within specifications with a +/-20% tolerance.The 2ml/hr flow on saf #1 yielded a rate of 2.10ml/hr, which is within specifications with a +/-20% tolerance.The 2ml/hr flow on saf #2 yielded a rate of 2.18ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr on saf #1 yielded a flow rate of 4.17ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 4ml/hr on saf #2 yielded a flow rate of 4.20ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 7ml/hr on saf #1 yielded a flow rate of 5.34ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 7ml/hr on saf #2 yielded a flow rate of 6.00ml/hr which is within specifications with a +/- 20% tolerance.A dremel was used to cut open the saf #1 and the flow control tubing observed under magnification.Crystalized medication was found in the 1ml/hr flow control tubing.The evaluation summary concluded that fast flow was not observed.During the flow accuracy test, the pump met specifications.During pressure pot testing, all flow rates met specifications using the average bladder pressure with the exception of the 1ml/hr rate on saf #1 which did not flow.At the start of the infusion verification it flowed indicating that it was obstructed after.Destructive analysis found crystalized medication in the 1ml/hr flow control tubing in saf #1.Based on the sample evaluation the root cause of the reported incident is unknown.The pump met all selectable flow rates during the flow rate testing.During pressure pot testing the saf#1 did not flow at 1ml/hr.The remaining flow rates were observed using the average bladder pressure during pressure pot testing.Crystalized medication was observed during destructive analysis for saf#1 at 1mlhr.A use review was performed to evaluate if the product was used appropriately, comparing use conditions with the requirements of the device instructions for use and labeling information.Based on the use review, it was observed that the user seemed to be laying on pump which could have been the potential cause of increased flow rate.None of the potential factors listed in the instructions for use were identified as the cause for the fast flow condition.However the sample investigation concluded that fast flow was not observed.Review of the dhr identified no issues observed during the manufacturing process which would have contributed to the incident observed.Therefore the root cause is unknown.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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6073578
• MDR Text Key: 59352481
• Report Number: 2026095-2016-00185
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

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: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: CB6007
• Device Catalogue Number: 101347700
• Device Lot Number: 0202361760
• Other Device ID Number: 30680651134777
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: I-FLOW CATHETER
• Patient Age: 52 YR
• Patient Weight: 130