MAUDE Adverse Event Report: PALL CORPORATION 1.2 MICRON FILTER; FILTER, INFUSION LINE

Lot Number GR00014527

Device Problems Backflow (1064); Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Event Description

Patient was running total parenteral nutrition (tpn) and lipids through a central line.Patient noticed bed sheet was wet due to leak in 1.2 micron filter that lipids was running through.Patient's mother noticed that tpn was backflowing into filter and leaking out while lipids were stopped.Registered nurse (rn) confirmed crack in 1.2 micron filter.Patient's mother states this is the third time this has happened since they have been admitted.

• Brand Name: 1.2 MICRON FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park dr; port washington NY 11050
• MDR Report Key: 17277386
• MDR Text Key: 318583804
• Report Number: 17277386
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: GR00014527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Male