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

Model Number	P400X2-14
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 21 feb 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.(b)(4).
Event or Problem Description
Halyard received a single report that referenced eight different incidences, which were associated with separate units, involving eight different patients.This is the fourth of eight reports.Refer to 2026095-2018-00011 for the first report, refer to 2026095-2018-00012 for the second report, refer to 2026095-2018-00013 for the third report, refer to 2026095-2018-00015 for the fifth report, refer to 2026095-2018-00016 for the sixth report, refer to 2026095-2018-00017 for the seventh report, refer to 2026095-2018-00018 for the eighth report.Infusion start time: unknown, infusion stop time: unknown, fill volume: 400 ml, flow rate: 6 ml/hr, procedure: unknown, cathplace: unknown.It was reported that the pump emptied faster than expected.The pump emptied after around 50 hours instead of the 66.7 hours anticipated.No injury reported.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW VARIABLE RATE CONTROLLER
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7287061
• Report Number: 2026095-2018-00014
• Device Sequence Number: 1133506
• Product Code: MEB
• UDI-Device Identifier: 30680651136856
• UDI-Public: 30680651136856
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2018

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
• Operator of Device: Other
• Device Model Number: P400X2-14
• Device Catalogue Number: 101368500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2018
• Initial Report FDA Received Date: 02/21/2018
• Patient Sequence Number: 1