MAUDE Adverse Event Report: PALL MEDICAL CELL WASH/INFUSION BAG

Model Number 791-03

Device Problem Leak/Splash (1354)

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

Event Date 05/18/2016

Event Type  malfunction  

Event Description

Second incident in 1 week regarding: pall medical cell wash/infusion bag set, code 791-03, lot 1553062, expiration 2018-05.After centrifugation of cord blood cells, leaking of product was noticed from the seam of cell wash/infusion bag set.First incident on (b)(6) 2016, the second on (b)(6) 2016.

• Brand Name: CELL WASH/INFUSION BAG
• Type of Device: CELL WASH/INFUSION BAG
• Manufacturer (Section D): PALL MEDICAL
• MDR Report Key: 5671052
• MDR Text Key: 45761665
• Report Number: MW5062404
• Device Sequence Number: 1
• Product Code: KSR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2018
• Device Model Number: 791-03
• Device Lot Number: 1553062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other