MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS HOMEPUMP ECLIPSE, 125 ML MAX; PUMP, INFUSION, ELASTOMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Kidney or Urinary Problem (4503)

Event Date 09/18/2022

Event Type  Injury  

Event Description

My wife has a bacterial infection that developed after spine surgery (neck) performed on (b)(6) 2022.The surgeon recommended picc line medication treatments from local infectious diseases consultants.My wife was given an iv picc line and started with cefepime medication on (b)(6) 2022.This medication dosage is 2pm, frequency every 8 hours and duration of forty-two (42) days.On sunday, (b)(6) 2022, my wife experienced trouble with urinating (she had the sensation to urinate but could only expelled small amounts of urine).The infectious diseases staff was contacted and my wife was told to drink more water and contact their office the following monday.My wife stopped taking additional treatments and contacted the infectious diseases staff today (b)(6) 2022.The id pharmacists said he was going to inform the md and get back to us for further instructions.Regards, (b)(6).

• Brand Name: AVANOS HOMEPUMP ECLIPSE, 125 ML MAX
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 15462239
• MDR Text Key: 300449077
• Report Number: MW5112178
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/19/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2022
• Patient Sequence Number: 1
• Treatment: ALIGN PROBIOTIC; AMLODIPINE; CEFAPIME 2GM; CYCLOBENZAPRINE; DOXEPIN ; GABAPENTIN ; HYDROCODONE; ONE DAY WOMENS VITAMIN; TYLENOL
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Hispanic
• Patient Race: White