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

Catalog Number UNKNOWN

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Pulmonary Embolism (1498); Dehydration (1807); Diarrhea (1811); Fatigue (1849)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being filed based on information received from the fda through a medwatch form.No information was provided on the initial reporter, the item number or batch of the pump involved, or the facility where the pump would have been filled.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.Without any contact information for the reporter or the user, no further information could be obtained.While b.Braun has elected to report this incident as an adverse event out of an abundance of caution, it should be noted that based on the information provided it cannot be conclusively determined that a product malfunction actually occurred.No adverse quality trends of this nature were identified during the complaint review process for the reported product family.If additional information becomes available, a follow up report will be submitted.

Event Description

As reported via medwatch : initial reporter took a call from a woman whose husband has pancreatic cancer and was on 5-fu continuous infusion.He started the infusion on a tuesday and it was supposed to last for a full week.Sometime between friday night and saturday the contents of the whole infusion had been infused.The patient was very sleepy on saturday and sunday and had terrible diarrhea.The doctor treated the 5-fu overdose with iv hydration.The patient had not fully recovered from this incident, and his blood counts were low.Initial reporter made a follow up call at a later date, and found out that the patient ended up being hospitalized for 7 days.He went to the outpatient clinic and ended up passing out.He was admitted to the hospital and diagnosed with a pulmonary embolism.The doctors told her maybe he laid on the tube and the heat caused the malfunction.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 200 boulder dr.; breinigsville, PA 18031 ; 4842408332
• MDR Report Key: 6572712
• MDR Text Key: 75361099
• Report Number: 9610825-2017-00092
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 05/17/2017,01/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2017
• Event Location: Home
• Date Report to Manufacturer: 05/17/2017
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization