MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML,; ELASTOMERIC - SAF

Model Number CB004

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

Patient Problems Seizures (2063); No Code Available (3191)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product is reported to be available but was not returned.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 09-jul-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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).The device was not returned.

Event Description

Fill volume: 550 ml, flow rate: 4 ml/hr, procedure: left rib fracture surgery, cathplace: left t2 & t5 paravertebral nerve blocks.Halyard received a single report that referenced two different incidences, which were associated with separate units, involving one patient.This is the first of two reports.Refer to 2026095-2017-00131 for the second event.It was reported that there were reported issues of flow rates due to altitude changes.A patient from (b)(6) hospital recently returned home to (b)(6) with on-q pumps and thought that the infusion rates may have changed after the flight due to altitude changes.Additional information received 19-jun-2017 stated patient connected to onq pumps on (b)(6) 2017 and traveled home to (b)(6) on (b)(6) 2017 via airplane.The onq was clamped during take off and again during landing phases of the flight.On (b)(6) 2017 the patient was contacted and there were no signs and symptoms of local anesthetic toxicity, there were no complaints about pump size or pain control changes.On (b)(6) 2017 a follow-up was performed from 1323 through 1329 and there were no reported signs of toxicity.The daughter called back at 1830 and reported that patient may have had a seizure.The patient was advised to go to the emergency department for medical attention and get the blocks removed.The blocks were removed by daughter and the tips were intact.On (b)(6) 2017 a follow-up phone call was made, the daughter and patient denied any further seizure activity like the occurrence on (b)(6) 2017.The daughter, whom is a medical doctor, reported she did every 2-hours neurological checks on patient (mother) and no signs and symptoms of seizure or deficits.The patients pain was tolerable with oral medications.The daughter stated the pumps seemed to have shrunk faster in 24-hours prior to the event and stated the devices seemed to be smaller faster than the first 24-hours.It was reported the patient stood up, eyes deviated upward and was not responding to verbal commands for few seconds.The patient's body was shaking and the patient was made to sit down and responsiveness returned.The patient denied tinnitus (prior to event and afterwards), denied numbness, but complained of weird taste yet no metallic taste.The patient complained of being very tired, decreased appetite, decreased urine output, but the bowel movements were regular.On (b)(6) 2017 the patient's daughter was told to take out the paravertebral catheters to be safe.The patient was instructed to seek medical attention due to possible seizure activity and possibility that patient may have hit head and had two superficial lacerations during the fall in prior 72-hours.Per the daughter the ct scan was negative for head trauma bleed.The patient was never taken to get medical attention per the daughter performed every 2-hour neurological checks and vitals on the patient through night of (b)(6) 2017 until the morning of (b)(6) 2017.At the time of disconnect the pumps were not empty.The "seizure" occurred at home.The patient was reported to be fine.No additional information was provided.

Manufacturer Narrative

All information reasonably known as of 25-aug-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML,
• 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, bc
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6713223
• MDR Text Key: 80024069
• Report Number: 2026095-2017-00130
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• 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,Followup
• Report Date: 08/09/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE 0.2%
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR