MAUDE Adverse Event Report: HALYARD HEALTH ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number	CBI006
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.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).
Event or Problem Description
Fill volume: unknown.Flow rate: 4ml / h.Procedure: unknown.Cathplace: leg.Infusion start time: (b)(6) 2018.Infusion stop time: (b)(6) 2018.It was reported that the pump finished earlier than expected, 17 hours after placement, on (b)(6) 2018.The patient reported that he did not use the bolus and has not touched the device.The sheets under the patient are not wet, and the catheter bandage is clean and dry.The pouch holds the pump are not wet.The patient reports that "sensation of anesthesia a little more important of his leg, manages to move but it is heavier".No further ropivacaine was provided to the patient.No further information provided.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for lot 0202786664 was reviewed and the product was produced according to product specifications.All information reasonably known as of 26 sep 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.
Additional Manufacturer Narrative
One used sample was returned for evaluation.A flow accuracy test was performed, and the flow rate was determined to be within specifications.A pressure pot test was performed on the flow control tubing, and was also found to be within specification.The bolus indicator was received at the top position with the button in the upward position.The select-a-flow flow rates were verified for infusion.The bolus had no issues being refilling or being dispensed and the dispense amount was within specification.All testing concluded that no fast flow was observed and the device was in specification.The complaint could not be confirmed as reported.No root cause could be determined.All information reasonably known as of 16 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical inc.Product is defective or caused serious injury.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7655658
• Report Number: 2026095-2018-00075
• Device Sequence Number: 16531521
• Product Code: MEB
• UDI-Device Identifier: 10680651134834
• UDI-Public: 10680651134834
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2018

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: 08/15/2019
• Device Model Number: CBI006
• Device Catalogue Number: 101348300
• Device Lot Number: 0202786664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 10/15/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 09/28/2018; 10/19/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE UNKNOWN DOSE
• Patient Age: 71 YR
• Patient Weight: 68