MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC PAIN RELIEF SYSTEM WITH DUAL SELECT-A-FLOW VARIABLE RATE CONTROLLERS; ELASTOMERIC - SAF

Model Number	CB4007
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Dizziness (2194); Numbness (2415); No Code Available (3191)
Date of Event	04/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: no code available - difficulty breathing, additional surgical procedure the actual complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 18-may-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 or Problem Description
Fill volume: 550 ml, flow rate: 4 ml/hr + 4 ml/hr, procedure: breast implant procedure, cathplace: bilateral breast, pump start time: 10 am on (b)(6) 2017, pump stop time: 5 or 6 pm on (b)(6) 2017.It was reported by the patient's mother that the patient had breast implant surgery on (b)(6) 2017, and on (b)(6) 2017, the patient experienced pain while laying down.It was noticed that the elastomeric pump was completely empty, and the time was noted to be around 5-6 pm.At the same time, the patient was experiencing the symptoms of dizziness, numbness to her arm, pain, and difficulty breathing.The next day, the patient's mother called the doctor to inform her of the pump issue and associated symptoms.The patient was seen by the doctor the same day, and a hematoma was discovered on her left breast in the area of the catheter insertion site.The pump was due to last 50 hours, but it completed in less than 24 hours.According to the doctor, the hematoma was caused by the fast flow of fluid causing high pressure into the patient's breast.The pump was removed on (b)(6) 2017.The patient had a second surgery (b)(6) 2017 to drain the hematoma site.The patient's symptoms dissipated after the surgery and the patient is noted to be in stable condition.The patient did not use hot therapy during infusion.Only cold therapy was used on her breasts.The pump was located in the black on q pouch around the patient's waist.No external pressure was applied to pump.

• Brand Name: ON-Q C-BLOC PAIN RELIEF SYSTEM WITH DUAL SELECT-A-FLOW VARIABLE RATE CONTROLLERS
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6581461
• Report Number: 2026095-2017-00089
• Device Sequence Number: 749944
• Product Code: MEB
• UDI-Device Identifier: 30680651316142
• UDI-Public: 30680651316142
• Combination Product (Y/N): N
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 04/25/2017

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
• Operator of Device: Patient Family Member or Friend
• Device Expiration Date: 06/30/2018
• Device Model Number: CB4007
• Device Catalogue Number: 103161402
• Device Lot Number: 0202331839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/22/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYDROCODONE; UNKNOWN ANTIBIOTICS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 19 YR
• Patient Weight: 44