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

Model Number REVACLEAR MAX

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Black fibers and dust were noted at the end of dialyzer when the package was opened.This occurred before use and was not associated with a patient.All dialyzers at the site with the same lot number were assessed and there were no other dialyzers affected.

• 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 Contact: ken finch ; 1101 jeter avenue; opelika, AL 36801 ; 3343641054
• MDR Report Key: 5941120
• MDR Text Key: 54401627
• Report Number: 3006552611-2016-00012
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K060195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REVACLEAR MAX
• Device Catalogue Number: 110634
• Device Lot Number: C416201601
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• 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