MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number	CBI004
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).There is no information provided regarding the return of the actual complaint product to the manufacturer.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.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: 400 ml, flow rate: 2-14 ml/hr, procedure: unknown, cathplace: unknown.It was reported that a patient experienced a high flow rate event associated with the use of a elastomeric infusion pump.It was also noted that there was a "blockness of the upper part of the leg." no further information was received.

• Brand Name: SURGPN,400X2-14,CB SAF,-,OQ,5
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6343114
• Report Number: 2026095-2017-00031
• Device Sequence Number: 10771606
• Product Code: MEB
• UDI-Device Identifier: 10680651134810
• UDI-Public: 10680651134810
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2017

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: Other
• Device Model Number: CBI004
• Device Catalogue Number: 101348100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/20/2017
• Patient Sequence Number: 1