MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* C-BLOC WITH DUAL SELECT-A-FLOW* 600 ML X 1-7 ML/HR + 1-7 ML/HR; ELASTOMERIC - SAF

Model Number	CB6007
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product is available but has not been received.The device history records review for the lot number 0202836606 was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no changes to the process and/or equipment that would have affected the manufacturing of the device.All information reasonably known as of 12-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.(b)(4).
Event or Problem Description
Fill volume: 750 ml, flow rate: 7 ml/hr, procedure: spinal fusion - 7 ml¿s.It was reported by the customer who stated, i was notified this morning that a patient¿s pump infused in under 48-hours.It was infusing at 7 ml¿s per hour per side.The patient was not injured.The clinicians removed the device and connected a second pump.The patient was complaining of no pain at the time.The pump was placed on (b)(6) 2018.No additional information was provided.
Additional Manufacturer Narrative
All information reasonably known as of (b)(6) 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 complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.
Event or Problem Description
Additional information received stated that the key was not removed prior to infusion.The patient was noted to be fine.

• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7344616
• Report Number: 2026095-2018-00027
• Device Sequence Number: 13841967
• Product Code: MEB
• UDI-Device Identifier: 30680651134777
• UDI-Public: 30680651134777
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: Physician
• Device Expiration Date: 04/15/2020
• Device Model Number: CB6007
• Device Catalogue Number: 101347704
• Device Lot Number: 0202836606
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 05/25/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2% ROPIVACAINE