MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES, 100 ML, 2 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number	C100020
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 actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 05-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 (b)(4).
Event or Problem Description
Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the second of three reports.Refer to 2026095-2020-00036 for the first event.Refer to 2026095-2020-00038 for the third event.Fill volume: 95 ml, flow rate: unknown, procedure: unknown, cathplace: unknown.It was reported the pump flowed in eight hours sooner than expected.There was no reported injury and no symptoms of fast flow.The patient was instructed to put the pump on chest at night while sleeping.Instructed that pump and tubing be placed outside of covers while sleeping.
Additional Manufacturer Narrative
Correction: d4 (lot# 0203140432).The device history record for the reported lot number ,0203140432, 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 13-apr-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 (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, 100 ML, 2 ML/HR (CONTAINS DEHP)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9799268
• Report Number: 2026095-2020-00037
• Device Sequence Number: 18993436
• Product Code: MEB
• UDI-Device Identifier: 10680651135619
• UDI-Public: 10680651135619
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 06/16/2021
• Device Model Number: C100020
• Device Catalogue Number: 101356105
• Device Lot Number: 0203140432
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 116