MAUDE Adverse Event Report: BAXTER HEALTHCARE - OPELIKA REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114745L

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

Patient Problems Erythema (1840); Burning Sensation (2146)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced a type one insensitivity reaction 30 minutes into starting treatment with a revaclaer 300.The reaction was further described as the patient felt a burning sensation in the upper and lower limbs.During evaluation, a spontaneous appearance of erythema in the lower limbs was observed.The patient was treated with 300mg of hydrocortisone, blood volume restitution and the patient was disconnected from the device and was placed under observation.At the time of the report, the burning sensation and presence of erythema in the lower limbs had resolved.The patient was reported to be feeling fine.No additional information is available.

Manufacturer Narrative

H4: the device was manufactured from nov 2 to nov 3, 2019.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REVACLEAR 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - OPELIKA; deerfield IL
• MDR Report Key: 9938128
• MDR Text Key: 189083721
• Report Number: 3006552611-2020-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123055
• UDI-Public: (01)07332414123055
• Combination Product (y/n): N
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

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: 11/15/2022
• Device Catalogue Number: 114745L
• Device Lot Number: C419128701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25 YR