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

Model Number 4540018-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Malaise (2359)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported incident are being made.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: early infusion completion when using 5fu.Three (3) specific events were reported by the user facility with no batch information (see below), however five (5) batches were reported.At this time, it is unknown for which batch each specific event occurred.B.Braun medical inc.Is reporting one mdr per batch for the issue, this report is for batch 19e15ge561.Other batches reported by user facility and corresponding mfr report numbers: 19e12ge561 - 9610825-2020-00203; 19e15ge562 - 9610825-2020-00207; 19d15ge561 - 9610825-2020-00205; 19e20ge561 - 9610825-2020-00206.Three (3) events reported by user facility: a patient came in for a 46 hour elastomeric pump at 1:30pm.The patient reported the pump appeared to be finished by 2pm the next day.The patient reported feeling crummy, but no interventions needed at this time.A patient came in after her tuesday infusion with adverse effects from a rapid 5-fu infusion.Her elastomeric pump was administered at 2:58pm on tuesday and was finished infusing by 10am wednesday morning.Another patient had a pump given at 3:08pm tuesday and it was completely infused by 7pm on wednesday.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (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.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• 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
• MDR Report Key: 10507088
• MDR Text Key: 233162858
• Report Number: 9610825-2020-00204
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

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: Lay User/Patient
• Device Expiration Date: 05/01/2024
• Device Model Number: 4540018-02
• Device Catalogue Number: 4540018-02
• Device Lot Number: 19E15GE561
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1