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

Model Number REVACLEAR

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A healthcare professional in reported they received a revaclear dialzyer that appeared to have a hair like fiber in the top of the header.

• 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 ; 2249487578
• MDR Report Key: 6187954
• MDR Text Key: 62791680
• Report Number: 3006552611-2016-00024
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REVACLEAR
• Device Catalogue Number: 110633
• Device Lot Number: C416117901
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other