MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number 4540040-02

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

Patient Problem Death (1802)

Event Date 02/28/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Although a batch number of j8k788 was reported, this is not a valid batch for an easypump product, therefore no batch information could be evaluated.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported via medwatch mw5084817: 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 utt.Received notification that patient has passed away on (b)(6) 2019 at home.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4842408332
• MDR Report Key: 8445463
• MDR Text Key: 139664719
• Report Number: 9610825-2019-00083
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448942
• UDI-Public: (01)04046964448942
• Combination Product (y/n): N
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4540040-02
• Device Catalogue Number: 4540040-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2019
• Distributor Facility Aware Date: 03/20/2019
• Event Location: Home
• Date Report to Manufacturer: 03/22/2019
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death