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	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method codes: actual device not evaluated, no testing methods performed.Results codes: no results available since no evaluation performed.Conclusion codes: device not returned.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 02-jul-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).Device not returned.
Event or Problem Description
Fill volume: 600 ml, flow rate: 7 ml/hr + 7 ml/hr = 14 ml/hr, procedure: rib fracture plating, cathplace: right side ribs.It was reported that a patient experienced a fast flow infusion.The pump was still attached to the patient at the time of the report, but the flow rate was adjusted to a very low rate.The patient was being monitored by vitals, and at the time, there were no signs or symptoms of toxicity or patient injury.The pump was noted to be under a blanket since the patient was using a bair hugger.The pump was set to last 42-hours, but after 24-hours, the pump had only about 100 ml.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 22-aug-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)(6).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.
Additional Manufacturer Narrative
The pump was received empty and used.The sample pump was evaluted and it was concluded that fast flow was not observed.During the flow accuracy test, the pump was within specifications.During pressure pot testing, the select-a-flow (saf) was also within specification except for the flow rate 1ml-hr which were below specification for both saf a and b.A potential contributor to the reported incident is the fact that the pump was placed under blankets, per the instructions for use, device should be worn outside the clothing at room temperature since a temperature increase can result in a faster flow rate; however, it cannot be confirmed.According with the dhr review, the production lot met all manufacturing and quality specifications.All information reasonably known as of 08-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).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.

• 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: 7667660
• Report Number: 2026095-2018-00076
• Device Sequence Number: 1050441
• Product Code: MEB
• UDI-Device Identifier: 30680651134777
• UDI-Public: 30680651134777
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2018

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: Other
• Device Expiration Date: 10/18/2019
• Device Model Number: CB6007
• Device Catalogue Number: 101347704
• Device Lot Number: 0202699012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 09/19/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 08/23/2018; 10/12/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.25 BUPIVACAINE; BAIR HUGGER