MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EASYPUMP ST 100 ML VOLUME 200 ML/HR RATE; PUMP, INFUSION, ELASTOMERIC

Lot Number J8K788

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

Patient Problems Death (1802); Fatigue (1849); Urinary Tract Infection (2120); Test Result (2695)

Event Date 02/28/2019

Event Type  Death  

Event Description

Patient on home iv therapy.Significant pmh dx: uti iv access device: sl-picc.On (b)(6): start of care and first dose.Tolerated without s/e or difficulty.On (b)(6): filled for 7 doses of ertapenem 1 gm iv daily.Patient dosing qd.On (b)(6): rph spoke with patient who stated his legs get fatigued and feel very "heavy" following ertapenem infusion.Checked references and spoke with md and not likely this effect is due to ertapenem infusions.Md advised to continue with therapy and if condition worsens in severity patient should let us know.On (b)(6): spoke to patient for a refill, he asked to wait, he has a md appt this afternoon.He has a concern about dosing with the ertapenem, he states that after the infusion his legs go weak/dead, he will call after his meeting with md.Spoke to patient later in the day and sent him four more doses.On (b)(6): patient stated he felt fatigue setting in but 10-12 hours after abx and he moved abx to approximately 2pm.He did state he was fatigued by putting out garbage and had not been prior to getting the uti.Comorbidities include emphysema, htn, renal transplant and diabetes.On (b)(6): therapy held due to elevated scr of 1.8.On (b)(6): labs drawn.Scr of 1.6, bun 39, glucose 160, phos 4.9, hgb 13.3, rdw 18.1, urine culture positive.On (b)(6): received notification that patient has passed away on (b)(6) 2019 at home.Patient was shipped a total of 12 x 1 gram ertapenem doses (mixed in 100 ml 0.9 percent sodium chloride and infused over 30 minutes via elastomeric pump.Not sure if he administered all 12 doses.Ertapenem ndc (b)(4), lot #r016393, exp february 28, 2020; consistent for all 12 doses shipped.Elastomeric device: easypump st 100 ml 200 ml/hr sodium chloride ndc (b)(4), lot # j8j795, exp january 31, 2021 and lot # j9k788, exp february 28, 2021.Sterile water for injection ndc (b)(4), lot # j8n083, exp april 30, 2021 and lot #j8n167, exp april 30, 2021.

• Brand Name: EASYPUMP ST 100 ML VOLUME 200 ML/HR RATE
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 8413929
• MDR Text Key: 138688052
• Report Number: MW5084817
• Device Sequence Number: 2
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/08/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Lot Number: J8K788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Weight: 79