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

Model Number C100020

Device Problem Infusion or Flow Problem (2964)

Patient Problems Tachycardia (2095); Sweating (2444)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.All information reasonably known as of 22 apr 2020 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).Device not returned.

Event Description

Fill volume: 100ml, flow rate: 2ml/hr, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that "patient reported to pharmacy that the medication from pump was completed 11 hours too early.Supposed to be infused over 46 hours.He said he became diaphoretic, felt his heartrate increase and went to er [emergency room], but did not receive any meds or treatment.Patient is fine and stable at home." additional information provided 13-apr-2020 included two images of the pump.Pump filled with fluorouracil.

Manufacturer Narrative

Additional information in a1, b5, and b6.The investigation remains in progress.All information reasonably known as of (b)(6)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.

Event Description

Additional information received (b)(6)2020 indicated the patient was "admitted to the hospital for bloodwork and toxicity test due to severe sweating and near fainting.[the patient] states he did not receive an iv [intravenous fluids] and was just observed overnight." patient was discharged the next day and was doing normal activities nothing different than usual, has used this pump before for infusions with no previous incidents.Patient has received additional chemotherapy treatments since incident.

Manufacturer Narrative

Additional information in section b5, d4, h4.The device history record for lot 0203018613 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation, but two photos were provided by the customer.As it was not possible to perform flow accuracy and pressure pot tests without the device, the root cause could not be determined.All information reasonably known as of (b)(6) 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.

Event Description

Additional information received 19-may-2020 indicated that since this incident, the patient has received two other courses without incident.The product was used in accordance with instructions.Facility conditions did not contribute to the incident and the patient states they did nothing different; they had been receiving this agent many times before.The customer is "very experienced.".

• Brand Name: HOMEPUMP C-SERIES
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9990405
• MDR Text Key: 230214850
• Report Number: 2026095-2020-00059
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 10680651135619
• UDI-Public: 10680651135619
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2021
• Device Model Number: C100020
• Device Catalogue Number: 101356105
• Device Lot Number: 0203018613
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 04/23/2020; 05/19/2020
• Supplement Dates FDA Received: 05/12/2020; 06/09/2020
• Patient Sequence Number: 1
• Patient Age: 67 YR