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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 22-jun-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: unknown, procedure: gastric bypass procedure, cathplace: two both near the tranverse abdominal plane, date of procedure: (b)(6) 2018.It was reported the surgeon was performing rounds on the patient when she noticed that the pump "seemed smaller than usual." the pump was in an on-q carrying bag and was on the bed next to the patient during infusion.There was no patient reported injury.It was unknown if the patient added external pressure to the pump or if the patient was using any warming devices.
Additional Manufacturer Narrative
The device history record for the reported lot number, 0202881274, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was received.The pump was received empty and used.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 600ml.Infusion verification was performed on all the functional select-a-flow (saf) flow rates and it flowed.The investigation summary concluded that fast flow was not observed for the pump.During the flow accuracy test, the pump was within specifications.During pressure pot testing, the saf was also within specification.All information reasonably known as of 04-oct-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: 7636183
• Report Number: 2026095-2018-00067
• Device Sequence Number: 19403547
• Product Code: MEB
• UDI-Device Identifier: 30680651134777
• UDI-Public: 30680651134777
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/18/2018

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 Model Number: CB6007
• Device Catalogue Number: 101347700
• Device Lot Number: 0202881274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 10/04/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2 % ROPIVACAINE