MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,CB006,CBCMBO,-,OQ,5; ELASTOMERIC - COMBO

Model Number	CB006
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	12/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 0.2% ropivacaine.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.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: 400 ml, flow rate: 4 ml/hr, procedure: shoulder scope with left acromioplasty for left rotator cuff tear, cathplace: interscalene block.It was reported that a 400 ml titratable bolus pump was placed for an interscalene block for a total shoulder replacement procedure.The patient was sent home with the pump on (b)(6) 2016, and they reported to anesthesia that the pump was empty on (b)(6) 2016.The bolus button was noted as not used.There was no patient injury and no reported adverse events.Additional information received stated that the pump was started around 12:30 pm on a monday, and it was empty around noon on tuesday.The patient did not experienced any adverse symptoms.The pump was filled at a hospital pharmacy and the red priming key was not removed.The pump was not placed at a site higher than the infusion location and there was no reported heat or pressure applied on the pump.
Additional Manufacturer Narrative
The pump was returned empty.A visual observation found the red prime key still inserted into the patient controlled analgesia (pca).A baxa repeater pump was used to refill the pump with 400ml of 0.9% saline.The pinch clamp was opened and the pump infused at all selectable flow rates.Flow accuracy testing was performed with the select-a-flow (saf) set to 14ml/hr.After 21.5 hours of testing, the pump yielded a flow rate of 20.15ml/hr which is above specifications with a +/- 20% tolerance.The pressure pot was performed on the selected-a-flow unit flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr without the filter.The saf unit was detached from the pump.The saf unit was connected to a pressure gauge with the pca section clamped off.The average bladder pressure used was 8.2psi.The saf flow rate 2ml/hr yielded a flow rate of 1.90ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.67ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 6.61ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 11.29ml/hr which is within specifications with a +/- 20% tolerance.The evaluation summary concludes that fast flow was observed due to the red priming key remaining in the pca.During the flow accuracy test, the pump flow rate was above specifications.During pressure pot testing, all flow rates met specifications using the average bladder pressure with the pca tubing clamped off.The root cause is associated with inappropriate use due to the broken red priming key that remained in the pca.The instructions for use state: "warning: do not pull the red tab upwards as breakage could occur (figure 3-b).If red tab is not removed or breaks while removing, continuous delivery will occur.This delivery may be significantly greater than the total flow rate (bolus + basal)." the device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 10-apr-2017 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: SURGPN,CB006,CBCMBO,-,OQ,5
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6226973
• Report Number: 2026095-2017-00001
• Device Sequence Number: 1027738
• Product Code: MEB
• UDI-Device Identifier: 10680651134742
• UDI-Public: 10680651134742
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

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: 10/31/2017
• Device Model Number: CB006
• Device Catalogue Number: 101347400
• Device Lot Number: 0202281751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 04/13/2017
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 137