MAUDE Adverse Event Report: BAXTER HEALTHCARE - OPELIKA REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	110634
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Respiratory Distress (2045)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial onset was reported as on (b)(6) 2018 and then on (b)(6) 2018 and lastly the (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient undergoing treatment with a revaclear max dialyzer experienced hypersensitivity reactions.On the date of onset of reactions, no medical intervention was reported for this occurrence.Two days later and 15 minutes into treatment with the same dialyzer, the patient experienced a ¿first anaphylactic reaction¿ and was later hospitalized that same day.The patient was treated with and an epi-pen (epinephrine injection).Two days later, the patient while undergoing treatment with the same device, experienced a "severe anaphylactic reaction".The patient's symptoms at time of reaction ranged from ¿hives, closing of throat, difficult breathing, weaving¿.An epi-pen was administered and the symptoms decreased.At the time of this report, the patient was still hospitalized.No additional information is available.
Additional Manufacturer Narrative
The device has been received, the sample was analyzed for pvp/nmp content per protocol and the results were within expectation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REVACLEAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - OPELIKA; opelika AL
• MDR Report Key: 7907912
• Report Number: 3006552611-2018-00014
• Device Sequence Number: 1683123
• Product Code: KDI
• UDI-Device Identifier: 07332414101701
• UDI-Public: 07332414101701
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 02/27/2020
• Device Catalogue Number: 110634
• Device Lot Number: C418205501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REVACLEAR DIALYZER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR