MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number	CB006
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional 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 24-aug-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).Device not returned.
Event or Problem Description
Fill volume: unknown flow rate: unknown procedure: unknown cathplace: unknown it was reported that the pump delivered the full volume of 0.2% ropivacaine within 24-hours and the red tab on the bolus had not been removed while the device was in use.Additionally, the nurse spoke to anesthetist and determined that the red tab on the bolus had not been removed and the pump had delivered the full volume of 0.2% ropivacaine within 24-hours.The infusion was stopped immediately and the patient underwent toxicity testing.The patient recovered with no injury reported.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6822976
• Report Number: 2026095-2017-00160
• Device Sequence Number: 819360
• Product Code: MEB
• UDI-Device Identifier: 30680651134746
• UDI-Public: 30680651134746
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: Nurse
• Device Model Number: CB006
• Device Catalogue Number: 101347405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/25/2017
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 60