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)
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 03-apr-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: unknown, flow rate: 6 ml/hr, procedure: midline laparotomy, cathplace: incision.It was reported that an elastomeric pump was titrated to 6 ml/hr and it emptied in 24 hours.The pump was incisionally placed for a midline laparotomy.The was no reported patient injury.
Additional Manufacturer Narrative
The evaluation summary concluded that a fast flow was not observed.The pump was refilled to nominal volume with a baxa repeater pump and infused at a all selectable rates.Flow accuracy testing was performed with the saf set to 6ml/hr.The second saf flow rate was below specification which may be attributed to the pump being filled more than once.Pressure pot on the saf flow rates was performed and all of the tested rates on saf #1 were within specification with a +/-20%.Pressure pot testing on saf #2 met specification except for the 2ml/hr line.A small amount of drug crystallization was found in the 2ml/hr line.The patient was not taking any other medication during use of the pump.The device history record for the reported lot number, 0202848438, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Root cause could not be determined.All information reasonably known as of 29-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.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).
Additional Manufacturer Narrative
The actual device was returned for evaluation.All information reasonably known as of 18-apr-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).

• Brand Name: ON-Q C-BLOC WITH DUAL SELECT-A-FLOW 600 ML X 1-7 ML/HR + 1-7 ML/HR
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7404671
• Report Number: 2026095-2018-00044
• Device Sequence Number: 11250094
• Product Code: MEB
• UDI-Device Identifier: 30680651134777
• UDI-Public: 30680651134777
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup,Followup
• Report Date (Section B): 05/08/2018

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: 05/05/2020
• Device Model Number: CB6007
• Device Catalogue Number: 101347700
• Device Lot Number: 0202848438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/09/2018; 05/08/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 04/20/2018; 05/29/2018
• Patient Sequence Number: 1