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

Catalog Number 114748

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.According to the photo a fluid droplet at the header cap is visible, but the cause of the reported failure is not visible.A batch review was conducted and there were no deviations found during the manufacture of this lot.There were (b)(4) dialyzers produced and distributed worldwide from this lot number.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

An external fluid leakage during treatment was reported from the ¿bottom¿ of the revaclear 300 dialyzer.There was no patient injury or medical intervention associated with this event.No additional information is available.

• 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
• Manufacturer (Section G): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7021748
• MDR Text Key: 92607813
• Report Number: 9611369-2017-00175
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 114748
• Device Lot Number: 7-9604-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1