MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q ELASTOMERIC PUMP, 400 ML X 4 ML/HR (2 ML/HR + 2 ML/HR), DUAL; ELASTOMERIC LFR

Model Number	P400X4D
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137); Vomiting (2144); Dizziness (2194)
Date of Event	07/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned 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.All information reasonably known as of 08-aug-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: unknown, flow rate: 4 ml/hr, procedure: lumbar fusion, cathplace: just above lower back.It was reported that a patient began to experienced symptoms of dizziness, blurred vision, vomiting and headache in the last 3 hours.The patient denied the symptom of metallic taste.The patient had a 400 ml 4 ml/hr dual pump 2+2 and only one catheter inserted.The other was clamped and not inserted into the skin.The patient was instructed to close the clamps on the tubing and to call an anesthesiologist.The patient's pain was an 8 out 10.Additional information received on 24-jul-2017 stated that the patient was doing much better and was in stable condition.The symptoms dissipated once the pump was discontinued and the catheter removed on (b)(6) 2017.The pump was noted to have run since (b)(6) 2017 and no symptoms were reported by the patient until (b)(6) 2017.The symptoms were at their worst on (b)(6)2017 when the patient experienced headache and blurry vision.When the pump was removed, it was almost empty, but the fill volume was not recalled.The catheter was located just above the lower back with and clean dry, and intact insertion site.No warming devices were use.No further information was received.
Additional Manufacturer Narrative
All information reasonably known as of (b)(6) 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: ON-Q ELASTOMERIC PUMP, 400 ML X 4 ML/HR (2 ML/HR + 2 ML/HR), DUAL
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6795213
• Report Number: 2026095-2017-00147
• Device Sequence Number: 985488
• Product Code: MEB
• UDI-Device Identifier: 30680651449352
• UDI-Public: 30680651449352
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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: 11/03/2019
• Device Model Number: P400X4D
• Device Catalogue Number: 101367603
• Device Lot Number: 0202710007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 11/03/2017
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 61