MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 600 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number	CB6004
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 0202859018, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual device is reported to be available but has not been returned for evaluation.All information reasonably known as of 15-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: 600 ml, flow rate: 8 ml/hr, procedure: ankle surgery, cathplace: unknown, date/time when infusion started: (b)(6) 2018 2:00 pm, date/time when infusion ended: (b)(6) 2018 8:00 pm.It was reported the onq pump finished in 54-hours, sooner than expected.The patient had surgery from 9:00 am to 12:00 pm and the pump was placed at 2:00 pm on monday (b)(6) 2018.The patient noticed the pump was empty on (b)(6) 2018 at 8:00 pm.The patient stated she never changed the rate from 8 ml/hr.The patient stated she never had any toxicity side effects (heart racing, metal taste in mouth, ringing in ears).The patient had orders to remove the pump when it was empty.The patient removed the pump.The patient was instructed to follow-up with the anesthesiologist and instruct the physician the pump finished early.There was no reported injury.
Additional Manufacturer Narrative
All information reasonably known as of 13-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.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 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.The investigation summary concluded that a fast flow was not observed for the pump.The failure was not confirmed.The root cause was not identified.All information reasonably known as of (b)(6) 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: 7615975
• Report Number: 2026095-2018-00065
• Device Sequence Number: 1529860
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: Patient Family Member or Friend
• Device Expiration Date: 05/15/2020
• Device Model Number: CB6004
• Device Catalogue Number: 101347603
• Device Lot Number: 0202859018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 10/03/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/17/2018; 10/26/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUPIVICAINE 0.125%
• Patient Age: 19 YR
• Patient Weight: 66