MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q SELECT A FLOW PUMP; ELASTOMERIC HFR

Model Number UNKNOWN

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

Patient Problems Nerve Damage (1979); Pain (1994); Sweating (2444); Decreased Sensitivity (2683); No Code Available (3191)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

The actual complaint product 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.All information reasonably known as of 28-dec-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.(b)(4).

Event Description

Fill volume: unknown, flow rate: unknown, procedure: bilateral total knee replacement, cathplace: sciatic tibial.It was reported that the experienced nerve damage after using the on-q select a flow pump.After surgery, the patient stated he lost sensation in both legs and feet after the device was placed on (b)(6) 2017.The device was in use from (b)(6) 2017.The device was discarded in the hospital by the staff.The patient was placed on oral pain medications following the use of the on-q, due to severe pain in both legs.Subsequently, the patient was also placed on lyrica for 2-weeks and trileptal for 1-week and these two medications were discontinued due to side effects.The patient stated experiencing extreme pain, night sweats, and loss of sensation.The symptoms were relayed to the physician during each follow-up visit.The patient was referred for a neurology assessment (1-month ago) by the orthopedic surgeon an after six months of follow-up visits.The patient was diagnosed with major nerve damage by neurology.No additional information was provided.

Manufacturer Narrative

All information reasonably known as of 15-feb-2018 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).

Event Description

Additional information received 31-jan-2018 stating the stock code remains unknown.The patient has visit three different neurologist since the incident occurred.The physicians tell the patient that there's nothing they can do to the treat nerve condition.The patient's family member states, "i don't know if they over dosed him or if they placed it wrong." the patient cannot feel his feet and walks with a cane.

Manufacturer Narrative

All information reasonably known as of 16-mar-2018 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.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).

Manufacturer Narrative

All information reasonably known as of 30-mar-2018 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.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

Additional information received via medwatch mw5075244, on (b)(6) 2018 stated permanent nerve damage in both legs after two total knee replacements due to the on-q pain ball with select flow, process of handling.

• Brand Name: ON-Q SELECT A FLOW PUMP
• Type of Device: ELASTOMERIC HFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7151177
• MDR Text Key: 95932410
• Report Number: 2026095-2017-00218
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2018

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: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/31/2018; 03/02/2018; 03/13/2018
• Supplement Dates FDA Received: 02/21/2018; 03/19/2018; 04/05/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 100