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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 0203076867, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 26-mar-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: 400 ml, flow rate: 4 ml/hr, procedure: total open hysterectomy, cathplace: abdomen.It was reported the pump looked empty yesterday evening on (b)(6) 2019, and on (b)(6) 2019 the patient wondered if it was really empty.The device was ordered to be removed on (b)(6) 2019.The patient called the hotline nurse.The patient removed the pump from the black bag and stated there was "no ball anymore, it is a straight tube." the infusion should lasted a four days.The patient stated she noticed the pump was empty yesterday evening.The patient denied having any side effects like ringing in the ears, metal taste in the mouth, tingling in fingers and a racing heart beat.The patient confirmed she did have orders to remove the pump at home when the infusion was completed.The hotline nurse instructed the patient on removing the pump and catheters.The hotline nurse stayed on the phone with the patient until she removed the pump.The patient removed the catheters easily and confirmed that each catheter had a black tip.The hotline nurse instructed the patient she removed the catheters fully and correctly.The patient had no further questions.The flow restrictor was taped to the patient.There were no crimps or kinks in the tubing.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 30-apr-2019 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 avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).
Additional Manufacturer Narrative
One sample device was returned.The device was evaluated.The investigation summary concluded a fast flow incident was not observed.The flow restrictors met specifications for both flow rate accuracy and pressure pot testing.The root cause could not be determined.All information reasonably known as of (b)(6) 2019 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 avanos medical, inc.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 avanos medical, inc.Avanos medical, inc.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 avanos medical, inc.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 an avanos medical, inc.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: 8457918
• Report Number: 2026095-2019-00049
• Device Sequence Number: 13560255
• Product Code: MEB
• UDI-Device Identifier: 30680651136764
• UDI-Public: 30680651136764
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2019

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: 02/13/2021
• Device Model Number: P400X4D
• Device Catalogue Number: 101367603
• Device Lot Number: 0203076867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 04/09/2019; 05/15/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/02/2019; 06/06/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUPIVICAINE 0.5%
• Patient Age: 46 YR
• Patient Weight: 99