MAUDE Adverse Event Report: GAMBRO HEMOFILTER SETS; PRISMA TUBING

Lot Number 13J1103G

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Prisma set found to be leaking blood from aeration chamber, upon inspection aeration set was cracked.A moderate sized pool of blood was on the floor.Set was taken down, blood was unable to be returned due to disk of embolizing air.

• Brand Name: HEMOFILTER SETS
• Type of Device: PRISMA TUBING
• Manufacturer (Section D): GAMBRO
• MDR Report Key: 3622316
• MDR Text Key: 4158674
• Report Number: MW5034248
• Device Sequence Number: 1
• Product Code: FJK
• 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: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 13J1103G
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR