MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH REVACLEAR 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number REVACLEAR 400

Device Problem Leak/Splash (1354)

Patient Problem Hemolysis (1886)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient in (b)(6) was undergoing a dialysis treatment which included a revaclear 400 dialyzer.During treatment, the machine alarmed "blood leak detected" and there was pink colored fluid at the drain that tested positive for blood.Treatment was stopped and the blood in the extracorporeal circuit was not returned to the patient resulting in an undisclosed blood loss.The patient was not symptomatic as a result of the blood loss and required no medical intervention.According to the head nurse, lab test were performed that confirmed a mild degree of hemolysis.Other than an h/h, and liver enzymes the specific tests and values were not provided.The patient was reportedly discharged home the following day.

• Brand Name: REVACLEAR 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO DIALYSATOREN GMBH; holger-crafoord-str. 26; hechingen 72379 ; GM 72379
• Manufacturer (Section G): GAMBRO DIALYSATOREN GMBH; holger-crafoord-str. 26; hechingen ; GM
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2249487578
• MDR Report Key: 6299045
• MDR Text Key: 66427308
• Report Number: 9611369-2017-00019
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: REVACLEAR 400
• Device Catalogue Number: 114746
• Device Lot Number: 6-7080-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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
• Patient Outcome(s): Other