MAUDE Adverse Event Report: FENWAL INTERNATIONAL, INC. AMICUS SEPARATOR SYSTEM; SEPARATOR, AUTOMATED, BLOOD

Model Number 4R4580

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 04/22/2015

Event Type  No Answer Provided  

Event Description

After hematopoietic progentior cell (hpc) product was collected and donor was disconnected from amicus, i stripped the product tubing with manual strippers to put all cells into bag.Upon doing this, the injection port's rubber type top became disconnected and some drops of hpc product were noted to have leaked out before roller clamp below site was clamped.I do not believe the roller clamp was closed, but potentially the tubing may have been kinked or occluded, which caused the occurrence.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD
• Manufacturer (Section D): FENWAL INTERNATIONAL, INC.; three corporate drive; lake zurich IL 60047
• MDR Report Key: 4804271
• MDR Text Key: 18037053
• Report Number: 4804271
• Device Sequence Number: 1
• Product Code: GKT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 4R4580
• Device Lot Number: FA14J13064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR