MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC PAIN RELIEF SYSTEM WITH DUAL SELECT-A-FLOW VARIABLE RATE CONTROLLERS; ELASTOMERIC - SAF

Model Number	CB4007
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method: the actual device was not returned and the lot number is unknown.As the lot is unknown, a review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.All information reasonably known as of 18-may-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).Sample not received for evaluation.
Event or Problem Description
Fill volume: 400 ml, flow rate: 7 ml/hr, procedure: a lap / converted to open ultra low hartmann's procedure plus, exteriorization of the bowel, cathplace: unknown.It was reported that a patient had a lap / converted to open ultra low hartmann's procedure plus exteriorization of the bowel and had an elastomeric pump placed.The pump was started at 19.30 on (b)(6), and at 16.00 on friday, it was noted that the pump was empty.The pump was expected to last approximately 28 hours, but it completed in 20 hours.The pump is not available for evaluation as it was disposed of.

• Brand Name: ON-Q C-BLOC PAIN RELIEF SYSTEM WITH DUAL SELECT-A-FLOW VARIABLE RATE CONTROLLERS
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6581468
• Report Number: 2026095-2017-00088
• Device Sequence Number: 13609159
• Product Code: MEB
• UDI-Device Identifier: 10680651316148
• UDI-Public: 10680651316148
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2017

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: CB4007
• Device Catalogue Number: 103161400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/22/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHIROCAINE