MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN ELASTOMERIC PUMP; ELASTOMERIC LFR

Model Number UNKNOWN

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

Patient Problems Pain (1994); Swelling (2091); Numbness (2415)

Event Date 02/16/2018

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 06-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.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 (b)(4).Device not returned.

Event Description

Fill volume: unknown, flow rate: unknown, procedure: left breast lumpectomy and reconstruction on (b)(6) 2018, cathplace: left breast.It was reported that a patient experienced signs and symptoms of numbness, tingling, and swelling during use and after use of an on-q pump.The patient also thinks that the pump infused at a faster rate than it was originally intended to.The patient had a the on-q pump was placed on the patient during surgery, and the patient was discharge from the hospital the same day as the procedure, (b)(6) 2018.On the night of (b)(6) 2018, the patient started to experience the numbness and tingling to her left arm, hand, and fingers, and toes.The patient also experienced pain in her left breast, as there was no pain relief felt.Consequently, the patient had to take her prescribed oral pain medication to manage the pain experienced in her left breast.In addition, the patient and her family experienced a difficult time locating the clamp to stop the on-q infusion.The patient called the doctor on saturday morning since the symptoms were noted to be getting worse and worse.The doctor instructed the patient to go to the emergency room, which the patient did on sunday, (b)(6) 2018.The patient had a variety of tests done, and nothing was able to explain why the patient was experiencing the numbness and tingling.The patient went to her doctor's office on monday, (b)(6) 2018, who was also unable to explain why she was experiencing numbness to her arm, fingers, and hand.The doctor referred the patient to a neurologist.The doctor removed her catheter and discontinued the pump.The pump was noted to be completely empty when it was removed on (b)(6) 2018, and it was not know by the patient how long it was run for since she was not given appropriate discharge instructions on pump usage.She felt that it was deflating a good amount per day and it was possible that it could have infused faster.When the pump was discontinued, the patient's symptoms stayed the same.However, later that day, the symptoms decreased slightly.Currently, the patient is still experiencing the numbness, tingling to her left arm, hand, and fingers and her left arm is also swollen.The patient was not using any warming devices during the pump's infusion.The pump was in the black carrying case sitting on the patient's lap or side of the patient.The patient slept on a recliner but was careful not to add any external pressure to the pump.Additional information received on (b)(6) 2018 from the patient stated that she was still experiencing numbness to her two left fingers and swelling to her left arm and hand.She saw a neurologist, but the neurologist was unable to determine the cause of the numbness.The neurologist wanted her to get more tests done.However, the patient stated she will seek another neurologist for the immediate future.No further information was provided regarding the event.

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: ELASTOMERIC LFR
• 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 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7329737
• MDR Text Key: 102074129
• Report Number: 2026095-2018-00031
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other