MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES ELASTOMERIC PUMP, 270 ML, 2 ML/HR (DEHP-FREE); 5FU

Model Number	C270020-10
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 20-nov-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).
Event or Problem Description
Fill volume: 243cc.Flow rate: 2ml/hr.Procedure: chemotherapy.Cathplace: unknown.It was reported the patient's pump was supposed to infuse in 120-hours but the patient came in on friday morning and the pump was empty.The pump emptied 24-hours early according to the pharmacy.The patient was stable with no side effects from the medication infusing in too fast.
Additional Manufacturer Narrative
The device history record for the reported lot number, 0203055288, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The pump was received empty.The tubing was not cut.The tubing distal luer had a luer connector with 5ml/sec max tubing connector and butterfly angled needle attachment (no other pump components were received with the complaint sample).The device was evaluated.The evaluation summary concluded the pump's distal luer end infused during infusion verification.The flow rate testing and pressure pot testing were within specifications.The reported failure could was not reproduced in the laboratory.A root cause was not identified.All information reasonably known as of 11-mar-2020 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 comp (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: HOMEPUMP C-SERIES ELASTOMERIC PUMP, 270 ML, 2 ML/HR (DEHP-FREE)
• Common Device Name: 5FU
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9357159
• Report Number: 2026095-2019-00186
• Device Sequence Number: 16918169
• Product Code: MEB
• UDI-Device Identifier: 30680651135668
• UDI-Public: 30680651135668
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 01/30/2021
• Device Model Number: C270020-10
• Device Catalogue Number: 103488204
• Device Lot Number: 0203055288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FU
• Patient Age: 64 YR
• Patient Weight: 41