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

Catalog Number 110633

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

Patient Problem Swelling (2091)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

N/a.

Event Description

A patient undergoing hemodialysis experienced multiple allergic reactions while being treated with a revaclear dialyzer.The patient experienced swelling of the tongue 1 hour into dialysis treatment, and the treatment was discontinued with blood restitution.The patient was admitted to the intensive care unit, diagnosed with angioedema and underwent airway monitoring.Treatment provided during the hospitalization was unknown.The patient remained hospitalized at the time of this report and was due to be released seven or eight days after the event occurred.The patient continued hemodialysis while hospitalized using a non-baxter dialyzer.No additional information is available.

• Brand Name: REVACLEAR
• 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 ; 2242702068
• MDR Report Key: 6589792
• MDR Text Key: 75915786
• Report Number: 3006552611-2017-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110633
• Device Lot Number: ASKU
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR