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

Model Number	720DH19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Low Blood Pressure/ Hypotension (1914); Chills (2191); Diaphoresis (2452)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional 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 # (b)(4).The device involved has not 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 or Problem Description
As reported by the user facility: patient had an adverse reaction upon starting dialysis with a diacap pro 19h filter.Approximately three (3) minutes after being connected to the machine the patient experienced a racing heart, tingling sensation to the jaw diaphoretic, blood pressure dropped suddenly and the patient became unresponsive.The treatment was immediately discontinued.The patient was treated by the code blue team according to the hospital's protocol.The patient was admitted to the hospital and had dialysis treatment the following day with a different dialyzer brand with no issues.
Additional 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 # (b)(4).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 manufacturer address was corrected in section d3 and g1-2.The address was corrected to: (b)(4).
Event or Problem Description
As reported by the user facility: patient had an adverse reaction upon starting dialysis with a diacap pro 19h filter.Approximately three (3) minutes after being connected to the machine the patient experienced a racing heart, tingling sensation to the jaw diaphoretic, blood pressure dropped suddenly and the patient became unresponsive.The treatment was immediately discontinued.The patient was treated by the code blue team according to the hospital's protocol.The patient was admitted to the hospital and had dialysis treatment the following day with a diferent dialyzer brand with no issues.

• Brand Name: DIACAP®
• Common Device Name: DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B.BRAUN AVITUM AG; schwarzenberger weg 73-79; ba-qm-de20; melsungen, 34212 ; GM 34212
• MDR Report Key: 7450415
• Report Number: 3004201412-2018-00011
• Device Sequence Number: 1544274
• Product Code: KDI
• UDI-Device Identifier: 04046964610813
• UDI-Public: (01)04046964610813
• Combination Product (Y/N): N
• Initial Reporter Country: CJ
• PMA/510(K) Number: K170574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018
• Report Date (Section F): 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
• Operator of Device: 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
• Distributor Facility Aware Date: 03/29/2018
• Date Report to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Date Report Sent to FDA: 06/04/2018