MAUDE Adverse Event Report: PALL NEWQUAY PALL ULTIPOR 100 BREATHING SYSTEM FILTER; FILTER, BACTERIAL, BREATHING SYSTEM

Model Number BB100E

Device Problem Partial Blockage (1065)

Patient Problem Respiratory Distress (2045)

Event Date 09/04/2017

Event Type  Injury  

Manufacturer Narrative

The implicated filter, along with one further unused filter from the same lot number, have been returned to pall for investigation.The returned devices will be evaluated and findings will be published, target for completion 03/nov/2017.

Event Description

It was initially reported to pall that a pall ultipor 100 breathing system filter was in use for 10 hours after which a patient was no longer able to be respirated.This was reportedly due to a flow difficulty issue.After receipt of the initial report from the customer, pall received further information of this incident from a customer report made to (b)(6) where there was an acute respiratory problem with one patient in icu.Whereby a patient in the surgical icu experienced acute respiratory distress, characterized by a lack of air flow which was documented by sensors on the respirator.The patient was cyanotic, experience bradycardia (25 bpm) but had a palpable pulse.The condition necessitated that the connection to the respirator be terminated.Manual resuscitation resulted in an immediate clinical stabilisation.Bilateral pneumothoraces were confirmed.Replacing the hme filter and return to the respirator alleviated the problem.Pall is not aware that there were any permanent adverse effects on the patient.It is important to note that some of the information provided in the original customer report to pall is not consistent with that which was submitted by the customer to (b)(6).We are currently in the process of working with the customer to obtain additional information and to clarify the details regarding this incident.Note: implicated reorder code bb100e is not registered and sold in the us.All fda information below is related to "like" products, under 510k k791307, which are registered for sale in the us.

Manufacturer Narrative

The returned used bb100e filter and the returned unused bb100e filter (from lot number 708602) were investigated by pall scientific and laboratory services.Both of the returned filters were subjected to airflow, hydrophobicity and surface tension testing.The used bb100e filter airflow (delta)p value could not be obtained as the pressure was higher than the maximum value achievable on the manometer.Liquid was also seen on the machine side of the used filter during initial expiratory airflow and post hydrophobicity airflow testing.The liquid that passed through the used filter appeared slightly discolored compared to the liquid from the unused bb100e filter.Surface tension testing showed that the fluid that went through the used filter from the patient side had a lower surface tension than that taken from the patient side of the unused filter.The returned used filter failed hydrophobicity testing.The unused bb100e filter passed all of the testing and gave results consistent with our current manufacturing claims.We can therefore confirm the customer's observation that the returned used bb100e filter had flow difficulties which was caused by the hydrophobicity of the media being compromised.The customer was able to provide pall with a further 5 unused bb100e filters from their stock of lot number 708602.All 5 of these additional filters were tested for airflow, hydrophobicity and surface tension.All filters passed testing and gave results consistent with our current manufacturing claims.A batch paperwork and non-conformance review was conducted for lot number 708602 and no anomalies were observed during this documentation review.All the machine specifications were checked and confirmed to be correct.All procedures were followed correctly.All quality control and release criteria were also reviewed and confirmed to be within specification.Furthermore, a review of our compliant database has confirmed that there have been no other reports of this nature for a bb100e filter with lot number 708602.In this instance our investigation was unable to identify the root cause of the reported flow difficulty.It was reported by the customer that the patient had been nebulised with 0.9% saline approximately one hour before the encountered flow difficulty, however it is unclear from the customer where the bb100e filter and nebuliser were positioned in the breathing circuit.In our experience if nebulisation occurs in the wrong place in a breathing circuit (i.E.The filter is placed in between the patient and the nebuliser) then a similar effect may be observed in that the hydrophobicity of the media could be compromised resulting in issues with flow difficulty.For customers that are using nebulisation we provide the following precaution statement in our instructions for use - "nebulisation parameters and drug regimens can be variable.During liquid drug nebulisation vigilance must be maintained to detect a possible increase in device resistance exhibited as increased airway pressure or the inability to deliver/exhale a full tidal volume.Although rare, the user should be prepared to immediately replace the device." for the reasons outlined above we do not believe that the returned used bb100e filter was a causal or contributory factor in this incident.Unless substantially significant information becomes available, this constitutes a final report.

• Brand Name: PALL ULTIPOR 100 BREATHING SYSTEM FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING SYSTEM
• Manufacturer (Section D): PALL NEWQUAY; st. columb major ind est; st. columb major, TR9 6 TT; UK TR9 6TT
• Manufacturer (Section G): PALL NEWQUAY; st. columb major ind est; st. columb major, TR9 6 TT; UK TR9 6TT
• Manufacturer Contact: richard borelli ; 25 harbor park drive; port washington, NY 11050 ; 5168019639
• MDR Report Key: 6918399
• MDR Text Key: 88397141
• Report Number: 9680602-2017-00003
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 00636207000743
• UDI-Public: 00636207000743
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K791307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BB100E
• Device Lot Number: 708602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention