MAUDE Adverse Event Report: HALYARD - IRVINE HYHSURGPN,600X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number	CB6004
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	02/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.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.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.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: 750 ml, flow rate: 8 ml/hr, procedure: partial knee replacement, cathplace: thigh, infusion start time: (b)(6) 2017 at 3pm, infusion stop time: (b)(6) 2017 at 4am.It was reported that a patient experienced an elastomeric infusion pump that infused too fast.The pump was placed on (b)(6) 2017 and was empty by (b)(6) 2017.It was noted that the pump lasted 58-hours instead of 90-hours and was set at 8 ml/hr the entire time.There was no reported patient adverse event.
Additional Manufacturer Narrative
One sample device was received with the original packaging.The pump was returned partially full and failed to infuse at the 2 and 4ml/hr rates.The pump was placed in a heated incubator at 88 degrees for 92 hours in an attempt to dislodge any of the particulates that were residing inside the component.When removed from the chamber infusion was observed at all rates.The pump was then refilled to nominal volume.Flow accuracy testing was performed with setting the saf to 8ml/hr.After 56.25 hours, the pump yielded a flow rate of 6.82ml/hr which is within specification 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.The average bladder pressure used was 7.39psi.The saf flow rate 2ml/hr yielded a flow rate of 2.25ml/hr, which is above specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.29ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 8.30ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.00ml/hr which is within specifications with a +/- 20% tolerance.The investigation summary concluded a that fast flow was not observed.A no flow was observed on the 2 and 4ml/hr lines due to some type of an occlusion inside the saf.Attempts were made to rehabilitate the pump which were successful.Flow accuracy testing was performed and the flow rate was below specification within a +/-20% tolerance.Pressure pot testing was performed and all tested rates met specification within a +/-20% tolerance.All information reasonably known as of 21-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.(b)(4).

• Brand Name: HYHSURGPN,600X2-14,CB SAF,-,OQ,5
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6396621
• Report Number: 2026095-2017-00037
• Device Sequence Number: 34643
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

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 Model Number: CB6004
• Device Catalogue Number: 101347603
• Device Lot Number: 0202531335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/25/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2% ROPIVACAINE; ICE MACHINE
• Patient Age: 70 YR