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U.S. Department of Health and Human Services

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

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B.BRAUN AVITUM AG DIACAP® DIALYZER, HIGH PERMEABILIT Back to Search Results
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); Diaphoresis (2452)
Event Date 03/29/2018
Event Type  Injury  
Manufacturer Narrative
(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 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.
 
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Brand NameDIACAP®
Type of DeviceDIALYZER, HIGH PERMEABILIT
Manufacturer (Section D)
B.BRAUN AVITUM AG
schwarzenberger weg 73-79
ba-qm-de20
melsungen, 34212
GM 34212
Manufacturer (Section G)
B.BRAUN AVITUM AG
schwarzenberger weg 73-79
ba-qm-de20
melsungen, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon blvd
allentown, PA 18109
4847197287
MDR Report Key7450415
MDR Text Key106193601
Report Number3004201412-2018-00011
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCJ
PMA/PMN Number
K170574
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2020
Device Model Number720DH19
Device Catalogue Number720DH19
Device Lot Number121880917
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2018
Distributor Facility Aware Date03/29/2018
Event Location No Information
Date Report to Manufacturer06/04/2018
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/23/2018 Patient Sequence Number: 1
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