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

Catalog Number 114748M

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 02/25/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during dialysis treatment with a revaclear 300, the patient experienced urticaria.For the second day in a row, the skin itching persisted.The following day, medical staff was informed.Upon physical examination, scattered purpura was observed on the ¿thoracodorsal region¿ and limbs.The revaclear was discontinued.Oral loratadine 10mg, for allergic reaction and intravenous dexamethasone 5mg for inflammation was administered to the patient.The patient¿s fever returned to ¿normal¿ and skin rash diminished after an unspecified span of time.No additional information is available.

Manufacturer Narrative

Additional information has been added to h6 and h10: 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
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - OPELIKA; 1101 jeter ave; opelika AL 36801
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16744966
• MDR Text Key: 313346971
• Report Number: 3006552611-2023-00012
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414126216
• UDI-Public: (01)07332414126216
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

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 Catalogue Number: 114748M
• Device Lot Number: C622302907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention