MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 400 ML; ELASTOMERIC HFR

Model Number	E401000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Type of Reportable Event	Serious Injury
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 (b)(6) 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).
Event or Problem Description
It was reported via fda medwatch / fda user facility report # mw5098016 the following information: fill volume: 350 ml, flow rate: 100ml/hr, procedure: antibiotic therapy, cathplace: unknown, infusion date(s): multiple infusions (b)(6), administered starting (b)(6) 2020, infusion time of each therapy: 3.5 hours, start and stop time: unknown, (patient self administered at home).Patient had been on vabomere 4gm iv q8h via gravity since (date redacted)2020 for treatment of persistent hepatic abscesses/bacteremia with resistant organisms starting (date redacted)2020 patient reported right sided flank pain associated with the end of his infusions pain reportedly started after he started using the elastomeric devices describes pain as burning sensation that seemed to lessen in severity ad time progressed after his infusions reports pain is with light touch and is 4/10 when he's up and walking no other systemic signs/symptoms or rash noted biliary drain noted to be working properly with stable labs (date redacted)2020 on (date redacted)2020.Patient was switched back to gravity infusions for remainder of his antibiotic therapy on (date redacted)2020, patient reported that pain resolved and that he did not experience any flank pain after switching back to gravity.Additional information received 17-dec-2020 stating the pharmacist stated the pump functioned as intended and stated the issue could be related to the drug and mode of therapy and this was the first time the drug vabomere was delivered to the patient.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30079227, 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 (b)(6) 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 ECLIPSE ELASTOMERIC PUMP, 400 ML
• Common Device Name: ELASTOMERIC HFR
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11150268
• Report Number: 2026095-2021-00005
• Device Sequence Number: 14433222
• Product Code: MEB
• UDI-Device Identifier: 00193494135546
• UDI-Public: 00193494135546
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: E401000
• Device Catalogue Number: N/A
• Device Lot Number: 30079227
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/25/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VABOMERE 4GM.
• Outcome Attributed to Adverse Event: Other