MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114746

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

Patient Problem Hemolysis (1886)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that at the end of treatment with a ak 98 dialysis machine, a revaclear 400 dialyzer and bl 207 blood lines, the patient experienced abdominal pain, nausea (towards the end of dialysis) and vomiting (after completion of treatment).The patient also experienced hemolysis and was hospitalized for the event.There was no medical invention reported for the event.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: upon further review of information provided, the cause of the reported event of hemolysis, was due to the patient¿s prior medical condition.Assessment of treatment data did not reveal a malfunction of the dialyzer that could have contributed to the reported event.Based on this assessment, the revaclear 400 is no longer suspect in the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REVACLEAR 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; deerfield IL
• MDR Report Key: 10088399
• MDR Text Key: 194830458
• Report Number: 9611369-2020-00060
• Device Sequence Number: 1
• Product Code: KDI
• 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
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114746
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AK 98 MACHINES; HD CONVENTIONAL LINE - BL207B
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 86