MAUDE Adverse Event Report: PALL NEWQUAY PALL "LIPIPOR" TNA FILTER; INTRAVENOUS FILTER

Model Number TNA1E

Device Problem Improper Flow or Infusion (2954)

Patient Problems Hyperglycemia (1905); Hyperthermia (1909); Hypoglycemia (1912); Respiratory Distress (2045); Tachycardia (2095)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

The tna1e filter associated with this incident was not retained by the user.The investigation is underway; currently we are awaiting the hospital to confirm additional occurrence details.Our findings will be "pulblished", target for completion january 4th, 2019.

Event Description

The customer reported to pall that air was observed downstream of a pall lipipor tna filter (tna1e), lot# 18-839.It was indicated that during administration, it was noted that the total volume of the parenteral bag (500ml) was distributed in 6 hours, as opposed to the normal distribution of 200ml in 14 hours.On (b)(6) the infusion line was disconnected from the child patient.Before the second reconnection, the nurse saw bubbles in the filter extension and then in the filter.Clinical consequences observed: hyperthermia, tachycardia, respiratory distress, hyperglycemia, then hypoglycemia.Actions undertaken: change of tubing, filter, and infusion pump.Note: implicated reorder code tna1e is not registered and sold in the us.All fda information below relates to a "like" product, reorder code tna1, which is registered for sale in the us.

Manufacturer Narrative

The implicated filter was requested for evaluation, unfortunately the implicated filter was not available for return and a direct evaluation was not possible.A review of our manufacturing records was conducted and has confirmed that product code tna1e lot # 18-839 was manufactured and quality control tested in accordance with our documented procedures and met all criteria required for release.No anomalies or non-conformities were identified.A complaint database search was conducted on the above part and lot number which confirmed no other occurrences of this nature were noted.Based on the information provided and the documentation review, it was determined that the filter was unlikely to be a contributing cause of the reported issue.No further action is proposed at this time.Unless substantially significant information becomes available, this constitutes a final report.

• Brand Name: PALL "LIPIPOR" TNA FILTER
• Type of Device: INTRAVENOUS FILTER
• Manufacturer (Section D): PALL NEWQUAY; st. columb major ind est; st. columb major, TR9 6 TT; UK TR9 6TT
• MDR Report Key: 8080716
• MDR Text Key: 127460521
• Report Number: 9680602-2018-00005
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• PMA/PMN Number: K905794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TNA1E
• Device Lot Number: 18-839
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention