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 Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	12/20/2017
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 in-progress.All information reasonably known as of 04-jan-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: 600 ml, flow rate: 14 ml/hr, procedure: spinal fusion, cathplace: back.It was reported by the patient's wife that the patient was in extreme pain and saying that the pump was empty.The patient's wife had to interpret for the patient since he was in too much pain.It was stated that the 600 ml pump was completely empty (emptied in 60 hours) and they were concerned that it infused too quickly.The pump was set at 5-7 ml at each port for a total of 10-14 ml-hr.It was noted that the patient was not able to get pain medication as well.The pain was stated to be 10/10.The patient was otherwise stable and there were no complaints of side effects from the medication.No further information was received.
Additional Manufacturer Narrative
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.No information is provided regarding the use of the product being outside of the recommendations from the instructions.The physician is a long time user of the pump and is not new to use of it.The end-user does not report any side effects that can be attributed to the use of the mediation in the pump.Root cause could not be determined.All information reasonably known as of 21-may-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.

• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7164875
• Report Number: 2026095-2018-00002
• Device Sequence Number: 1340572
• Product Code: MEB
• UDI-Device Identifier: 30680651134777
• UDI-Public: 30680651134777
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/30/2018

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: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: CB6007
• Device Catalogue Number: 101347700
• Device Lot Number: 0202775575
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 05/24/2018
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 82