MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,CB005,CBCMBO,-,OQ,5; ELASTOMERIC - COMBO

Model Number CB005

Device Problem Sticking (1597)

Patient Problem Pain (1994)

Event Date 11/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product involved in the report has been returned and is being processed for evaluation.The device history record for the lot number involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.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).

Event Description

Fill volume: unknown, flow rate: 5 ,7, 5 ml/hr, procedure: total knee replacement, cathplace: unknown.It was reported by a female patient that she used on demand button of her pump at 12:30pm, and it did not pop back up after she used it by the time she reported this event at 9:15pm.She specified that her pain level was a 2/10, and that there was still a large amount of medication left in the bag.There were no symptoms of toxicity.She was instructed to immediately clamp the tubing and call her anesthesiologist.Currently, the patient's pain is described to be a 3/10.Additional information received on 29nov2016 stated this pump was the second one from surgery.It was installed before they left the hospital on (b)(6) 2016.The pump was clamped accidentally, from 2pm that day until 4am on (b)(6) 2016.It was unclamped, the ondemand button was pushed once and it worked well.On (b)(6) 2016 at about noon, the patient attempted to push the button again.However, this time the button was stuck and the yellow indicator was at the bottom.The patient called a doctor and was advised to turn the rate up from 5 ml/hr to 7 ml/hr sinec the patient was in a lot of pain.The pump was noted to be working well at the time, and the ondemand button did pop back up after the device was dropped on the floor 8 hours later.The patient turned the rate back down to 5 ml/hr and used it until empty on the morning of (b)(6) 2016.There was no reported local anesthetic toxicity symptoms.

Manufacturer Narrative

Corrected data- date sample received.The pump was received empty.The pump was refilled to the nominal value of 400 ml using a baxa repeater pump with 0.9% of saline.When opening the pinch clamp, infusion was not observed.An empty small syringe was connected at the distal luer and negative aspiration (suction) was applied a few times, no flow was obtained.The tubing was cut a few inches distal to the blue connector (base of the pump) and infusion was observed.The tubing was bonded back together with a male and female luer using cyclohexanone.The tubing was cut 2 inches distal to the filter and infusion was observed.The tubing was cut 1 inch distal to the saf (select-a-flow) and infusion was not observed.The sample was placed in a heated incubator at 88 degrees for 24 hours to dislodge any of the particulates that were residing inside the component.When removed from the chamber, the remaining tubing was connected to an air source of 15 psi for approximately 1 hour in an attempt to dislodge any remaining particulate matter.A syringe with warm 0.9% of saline was inserted into the proximal end of the saf unit but infusion was not observed.The sample was unable to be rehabilitated.Destructive analysis was performed on the saf unit using a dremel to examine for crystallized medication.The saf unit was examined under a microscope magnified at 1.6x and 3.2x and observed crystallized medication in all the saf micro tubing¿s.The bolus indicator received at the top position with the button in the upward position.Bolus button testing was performed with the pressure set to 8.Female luer using cyclohexanone.The bolus unit was attached to the pressure gauge.The bolus button safety test results yielded an average delivery amount of 2.13 g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 5.04 g, all results are within specifications.The evaluation summary concluded that infusion was not observed due to crystallized medication in the saf inner tubing¿s.The sample was unable to rehabilitate.The bolus button functioned as intended and observed no issues.During pca safety bolus test and bolus volume testing, results met specifications using the average bladder pressure.The root cause is attributed to a contaminated component.Infusion was not observed due to crystallized medication in the saf inner tubing¿s.The sample was unable to rehabilitate.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).

• Brand Name: SURGPN,CB005,CBCMBO,-,OQ,5
• Type of Device: ELASTOMERIC - COMBO
• 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: 6150626
• MDR Text Key: 62352921
• Report Number: 2026095-2016-00217
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

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: 03/31/2018
• Device Model Number: CB005
• Device Catalogue Number: 101347304
• Device Lot Number: 0202409730
• Other Device ID Number: 30680651134739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ORAL OXYCODONE 2TB Q3HR; THE 0.2% ROPIVACAINE
• Patient Age: 74 YR
• Patient Weight: 113