MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number C270020

Device Problem Infusion or Flow Problem (2964)

Patient Problems Nausea (1970); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Code not available: mouth sores.The actual device is reported to be available but has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 16-feb-2021 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

Fill volume: 270 ml, flow rate: 2 ml/hr , procedure: unknown, cathplace: unknown, start date:(b)(6) 2021 at 12:28pm, stop date:(b)(6) 2021 at 11:31pm.It was reported a patient received a 5fu infusion over approximately 48-hours last week instead of the expected 96-hours period.Additional information received 01-feb-2021 stated the patient reported mouth sores and nausea as a result of the fast flow incident.The physician prescribed zofran and magic mouthwash as treatment.Patient is reportedly "fine." the patient informed the nurse that the infusion started and finished early,.

Event Description

Additional information was received on 08-mar-2021 via fda medwatch / fda user facility report #mw5099150.The following information was provided: [patient] pt received halyard homepump c series elastomeric pump model # c270020 270ml/hr to infuse fluorouracil over 96 hours.Pump attached at (b)(6) 2021 at 1228.Clinic contacted (b)(6) 2021 [at] 1131 that patient was concerned that the pump was empty and that she noticed it empty last night when the pt arrived at clinic, rn confirmed the correct pump was dispensed and calculations were correct.No obvious leaks or defects with pump per pt.Pt experienced nausea and mouth sores from shorter than expected duration of infusion.

Manufacturer Narrative

All information reasonably known as of 23-mar-2021 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.

Manufacturer Narrative

The device history record for the reported lot number, 0203068909, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was returned and evaluated.No fast flow event was observed during the sample evaluation, however, a leakage was observed at the filter vent hole.The root cause could not be determined.All information reasonably known as of 23-apr-2021 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, 270 ML, 2 ML/HR (CONTAINS DEHP)
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11345942
• MDR Text Key: 280446746
• Report Number: 2026095-2021-00037
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494135669
• UDI-Public: 00193494135669
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2021

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: Health Professional
• Device Expiration Date: 02/13/2021
• Device Model Number: C270020
• Device Catalogue Number: N/A
• Device Lot Number: 0203068909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/05/2021; 03/29/2021
• Supplement Dates FDA Received: 03/23/2021; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5FU.
• Patient Age: 66 YR
• Patient Weight: 68