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

Catalog Number 114745

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Fainting (1847)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that a revaclear 300 dialyzer leaked, leading to fluid loss.The reporter stated that the ultrafiltration on the baxter dialysis machine was set at 600ml for 2 hours of treatment time.However, 1 hour and 15 minutes into treatment, the home patient¿s blood pressure dropped suddenly, and the patient momentarily lost consciousness.The patient recovered and called the home hemodialysis (hhd) nurse at the hospital.The patient received instructions from the hhd nurse on discontinuing the treatment; however, the patient was unable to return the blood in the circuit.Afterwards, the patient noticed that there had been a leakage from the dialysate connector.The patient weighed themselves and reported that they had lost (b)(6) fluid due to the leak.The hhd nurse reported that they suspected the hose was incorrectly attached to dialyzer.The patient did not receive any medical intervention following the event.No further clinical consequences were reported.No additional information is available.

Manufacturer Narrative

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 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 7285871
• MDR Text Key: 100562684
• Report Number: 9611369-2018-00023
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 05413765546310
• UDI-Public: (01)05413765546310
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 114745
• Device Lot Number: 79254H01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AK 96 MACHINE; AK 96 MACHINE
• Patient Outcome(s): Other
• Patient Age: 61 YR