MAUDE Adverse Event Report: B.BRAUN AVITUM AG DIACAP®; DIALYZER, HIGH PERMEABILIT

Model Number 720DH19

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

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Chills (2191)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device involved has been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: patient had an adverse reaction upon starting dialysis with a diacap pro 19h filter.Immediately after being connected to the machine the patient experienced fever, chills, a drifting away feeling, difficulty breathing and a drop in blood pressure.The treatment was stopped.Oxygen was administered to the patient.A normal saline bolus was infused.The blood line and dialyzer were discarded.A new blood line and a different dialyzer brand were set up.A new treatment was started approximately 30 minutes later without any incidents.

Manufacturer Narrative

Exemption number e2015011.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum saxonia gmbh (manufacturer).This report has been identified as b.Braun avitum internal report # 400384500.Two (2) unused dialyzers of batch 121880917 were returned for investigation.The investigation of the returned samples did not show any product deviation.The review of the device history record of the fiber and the dialyzer, as well as of the incoming inspection certificates of the materials in contact with the blood (potting material, blood caps, sealing rings), did not show any deviation.The biocompatibility of all components of the diacap pro dialyzers, as well as the finished product, is tested according to din en iso 10993.The review of the complaint database shows four (4) cases during the last three (3) years reporting that patients developed symptoms during a therapy with a diacap pro dialyzer.In none of these cases was there a product deviation.Batch 121880917 was manufactured in september 2017 and no other complaints were reported against this batch.It is known that hypersensitive reactions may occur on rare occassions during the use of dialyzers.The instructions for use of the diacap pro informs about potential side effects as follows: hypersensitivity reactoins may occur in rare cases during dialysis.If hypersensitivity reactions are severe, the dialysis must be discontinued and appropriate medical treatment should be initiated.The blood from the extracorporeal system must not be returned to the patient.Diacap pro dialyzers are gamma sterilized in an oxygen-free environment and do not contain any sterilization residuals.The medical assessment of the current case by a nephrologist indicate that the described symptoms are compatible with such a hypersensitive reaction.Although there is no evidence of product deviation, the manufacturer is conducting additional investigations regarding the patients having symptoms during therapy.If additional pertinent information becomes available a follow-up report will be filed.Correction: the address was corrected to: b.Braun avitum ag.Schwarzenberger weg 73-79.Melsungen 34212, gm.

Event Description

As reported by the user facility: patient had an adverse reaction upon starting dialysis with a diacap pro 19h filter.Immediately after being connected to the machine the patient experienced fever, chills, a drifting away feeling, difficulty breathing and a drop in blood pressure.The treatment was stopped.Oxygen was administered to the patient.A normal saline bolus was infused.The blood line and dialyzer were discarded.A new blood line and a different dialyzer brand were set up.A new treatment was started approximately 30 minutes later without any incidents.

• Brand Name: DIACAP®
• Type of Device: DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B.BRAUN AVITUM AG; schwarzenberger weg 73-79; ba-qm-de20; melsungen, 34212 ; GM 34212
• MDR Report Key: 7458299
• MDR Text Key: 106430014
• Report Number: 3004201412-2018-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046964610813
• UDI-Public: (01)04046964610813
• Combination Product (y/n): N
• PMA/PMN Number: K170574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 720DH19
• Device Catalogue Number: 720DH19
• Device Lot Number: 121880917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2018
• Distributor Facility Aware Date: 03/29/2018
• Date Report to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR