MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS REVACLEAR MAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number REVACLEAR MAX

Device Problem Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Na.

Event Description

A patient was undergoing a dialysis treatment which included a phoenix machine, cartridge blood line and revaclear max dialyzer.The patient has two vascular access sites; a right upper arm av fistula and a tunneled right subclavin hd catheter.Due to several months of difficulty cannulating the fistula, the arterial blood line was connected to the catheter and the venous line connected to the av fistula via a 17 gauge needle.During the last 30 minutes of the dialysis treatment on (b)(6) , the venous needle infiltrated with active bleeding.Treatment was terminated and pressure applied to the site; bleeding eventually stopped and the patient was discharged home in stable condition.The following day the patient was admitted to the hospital with hematuria and dizziness.The patient's lab work revealed anemia and was also suggestive of hemolysis; the urine analysis confirmed a urinary tract infection.The patient's vital sings were stable, afebrile, no back pain, no frank bleeding and no signs of anything hemodynamically significant.The patient was transfused with a unit of blood.The hematuria spontaneously resolved and the patient was discharged from the hospital a few days later.The phoenix machine was inspected and found to be operating within manufacturer's specification.The disposables used at the time of treatment were discarded and no longer available for analysis.

• Brand Name: REVACLEAR MAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS; 1101 jeter avenue; opelika AL
• Manufacturer (Section G): GAMBRO RENAL PRODUCTS; 1101 jeter avenue; opelika AL 36801
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2249487578
• MDR Report Key: 6266269
• MDR Text Key: 65374391
• Report Number: 3006552611-2017-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/20/2017

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 Model Number: REVACLEAR MAX
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: PHOENIX, CARTRIDGE
• Patient Outcome(s): Hospitalization