MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS INC. REVACLEAR MAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT

Lot Number C417202601

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2017

Event Type  Injury  

Event Description

Black particulate noted in dialyzer.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: doesn't apply.Event reappeared after reintroduction: doesn't apply.Revaclear max lot number c417202601 used on 03/28/2017.

• Brand Name: REVACLEAR MAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS INC. ; englewood CO
• MDR Report Key: 6446437
• MDR Text Key: 71387746
• Report Number: MW5068747
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: C417202601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 110