MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES; ELASTOMERIC LFR

Model Number	C100020
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 0202736643 was reviewed and the product was produced according to product specifications.All information reasonably known as of 20 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: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that the device "was supposed to run in 46 hours, but when the patient woke up at 6 am ¿ 39 hours in ¿ the pump was empty." additional information received from the user facility on 03-may-2019 indicated there were "no immediate adverse effects.Unknown effect on clinical outcome.".
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.
Event or Problem Description
Fill volume: 95 ml; flow rate: 2 ml/hr; procedure: unknown; cathplace: unknown.Infusion start time: (b)(6) 2019; 1500.Infusion stop time: (b)(6) 2019; 0600.Additional information received 26-jun-2019 includes the fill volume, flow rate, and infusion start/stop times listed above.According to the complainant, infusion ended at 6am "or sooner, when patient woke up at 6am it was empty so unable to say exactly what time during the night." drug was 5fu [fluorouracil] and normal saline, expected dosage 625mg.Delivered dosage was listed as "assumption is entire dosage as the pump was empty.".
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.The pump was received empty.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 100ml.A fast flow was not observed for the pump.During the flow accuracy test, the pump was within specifications.During pressure pot testing, the flow rate setting met specifications as well.Root cause could not be determined.All information reasonably known as of 17 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: HOMEPUMP C-SERIES
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8628395
• Report Number: 2026095-2019-00092
• Device Sequence Number: 1876185
• Product Code: MEB
• UDI-Device Identifier: 10680651135619
• UDI-Public: 10680651135619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2019

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: 12/10/2019
• Device Model Number: C100020
• Device Catalogue Number: 101356100
• Device Lot Number: 0202736643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 06/26/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/19/2019; 07/18/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLUOROURACIL; NORMAL SALINE
• Patient Age: 25 YR
• Patient Weight: 71