MAUDE Adverse Event Report: HALYARD - IRVINE HYHSURGPN,400X10,CBI,-,OQ,5; ELASTOMERIC LFR

Model Number	CBI002
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was reported to be available but has not yet been returned.The device history record for the reported lot number, 0202588198 in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 23-jun-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).
Event or Problem Description
Fill volume: 400 ml, flow rate: 10/ml/hr, procedure: midline laparotomy, cathplace: rectus sheath block, date/time infusion start: (b)(6) 2017 pm, date/time infusion stop: (b)(6) 2017 pm.A report was received stating that fast flow event had occurred.The device was noted to be empty within 24 hours of initial start.Additional information received 14-jun-2017 stated the nurse discovered the empty device.The patient was on the surgical high dependency unit.The patient was not receiving warming or cooling therapy.The pump and tubing was not under a warming or cooling device.The pump was placed under the blankets below the infusion site during infusion.There was no reported injury.No further information to be provided.

• Brand Name: HYHSURGPN,400X10,CBI,-,OQ,5
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6673456
• Report Number: 2026095-2017-00122
• Device Sequence Number: 18850159
• Product Code: MEB
• UDI-Device Identifier: 30680651134791
• UDI-Public: 30680651134791
• 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: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2017

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: Nurse
• Device Expiration Date: 05/19/2019
• Device Model Number: CBI002
• Device Catalogue Number: 101347902
• Device Lot Number: 0202588198
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/28/2017
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 130