MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PUMP WITH ONDEMAND; CATHETERS

Model Number	PS12504
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0202775489 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 may 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: 330 ml, flow rate: 5ml/hr, procedure: breast surgery, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving the same patient.This is the first of three reports.Refer to 2026095-2019-00079 for the second report.Refer to 2026095-2019-00080 for the third report.It was reported that a fast flow event occurred."after 46 hours only 55ml was left, instead of approx 100[ml]." three units are involved.No injury was reported.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The investigation is in progress.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 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 an avanos medical inc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.One on-q pump, 270x5, was received empty and used.The tubing was disconnected from the glass orifice inlet; therefore, the sample cannot be evaluated.The root cause could not be identified.All information reasonably known as of 01 jul 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 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 an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: ON-Q PUMP WITH ONDEMAND
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8584415
• Report Number: 2026095-2019-00078
• Device Sequence Number: 3019889
• Product Code: MEB
• UDI-Device Identifier: 30680651136467
• UDI-Public: 30680651136467
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2019

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: Health Professional
• Device Expiration Date: 01/26/2020
• Device Model Number: PS12504
• Device Catalogue Number: 101364600
• Device Lot Number: 0202775489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 06/12/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/06/2019; 07/08/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE 5MG/ML