MAUDE Adverse Event Report: PALL CORPORATION ULTIPOR 25 ANESTHESIA BREATHING CIRCUIT SYSTEM FILTER; BREATHING FILTER

Model Number BB25AB

Device Problems Partial Blockage (1065); Improper Flow or Infusion (2954)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Ventilator Dependent (2395)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Patient had hepa/hme filter when in use for a travel with a travel ventilator.Hepa/hme inadvertently left on for 14 hours after return from travel and connected to ventilator with heated wire circuit.Filter accumulated moisture and clogged.Unstable patient decompensated and lost pulse briefly -code x 20sec-1min before returning pulse.Original intended procedure was humidification for travel to radiology procedure.Other information about the patient that may have influenced the outcome of the event: multiple factors -patient recently had rvad removed and was on aerosolized veletri (not delivering with filter in line) so climbing pa pressures could be attributed to either.Variable tidal volumes on psv.Was on a dilaudid drip and treated for pain and hour prior to event.

Manufacturer Narrative

Our company became aware of an event with a medical device it markets from a letter and report (b)(4) it received from the agency's medical device reporting team.After records search, it was determined that the event detailed in report (b)(4) was not reported to our complaint handling system prior to receipt of the agency's letter.After receiving the letter and report a review determined that a medical device report (mdr) and formal investigation was required.As stated on the medwatch form, the patient was under pressure support ventilation (psv) presumably with variable tidal volumes and airway pressures, which can lead to transient hypercapnia or hypoxia.It was also stated that the patient recently had a right ventricular assist device (rvad) removed and was being treated with dilaudid (hydromorphone).A side effect of this opioid analgesic is a suppression of ventilatory drive (potentially resulting in respiratory distress), which may have been a contributing factor to the patient decompensating and losing pulse for a brief period of time (20 sec - 1 min).Patients, in general, supported by mechanical ventilation require close clinical monitoring.The device labelling's warning statement provides information on considerations needed in certain therapy modes.In particular, the warnings state: "ventilator alarms should be in use at all times." assuming that such precautions were observed, an alarm most likely triggered interventions of the clinical staff to identify accumulated moisture in the filter and led to corrective actions, which however did not prevent the reported decompensation and brief loss of pulse.The implicated filter has not been returned to the company.We can therefore not confirm that its resistance to airflow had been impaired.The manufacturing data for neither the pall bb25ab filter lot number nor the unique device identifier (udi) number for the filter in use during the event were provided by neither the user facility nor the health care professional who provided the details surrounding the event of the medwatch form.This information is printed on the unit package and was not recorded by the health care professional before the filter and packaging were discarded.In absence of the lot number from the health care professional, a batch review was conducted on three (3) recent lot numbers sent to the hospital reported on the medwatch form with no issue found.The results of a separate investigation showed that there were no previous reports of the same failure mode with this breathing filter model.The pall bb25ab filter is indicated for use in anesthesia, whereas the information provided by a health care professional on the medwatch form mentions that the product was being used during the patient's transport while using a transport ventilator, and later in an intensive care ventilation setting, which is outside of the bb25ab's indication for anesthesia delivery.As stated on the medwatch report submitted by the user facility or the health care professional, the original intended procedure was humification for transport to another clinical (radiology) procedure.The anesthesia ventilation setting indicated for the pall bb25ab filter is significantly different from the environment experienced during transport and subsequent respiratory therapy in that anesthesia ventilation does not require and therefore usually precludes the use of active humidification.As stated on the medwatch report, the filter was inadvertently left on for 14 hours after return from travel, there was no statement as to whether the filter was visually inspected for accumulated moisture after return from travel there was also no indication of the time the patient was travelling for.Summary in conclusion, based on our evaluation of the detailed description of the circumstances provided by a health care professional surrounding the event occurrence, it was determined that the implicated product was unlikely to be the sole cause for the reported event.The reduction in flow in the implicated filter is likely to be related to the medication nebulized and/or customer's use of the filter (used outside of indications).Our evaluation does not indicate that it was a consequence of the production, quality or performance of the product.It is considered an isolated incidence and therefore no field action will be taken.Unless substantially significant information becomes available, this constitutes a final report.No files attached.

Event Description

Patient had hepa/hme filter when in use for a travel with a travel ventilator.Hepa/hme inadvertently left on for 14 hours after return from travel and connected to ventilator with heated wire circuit.Filter accumulated moisture and clogged.Unstable patient decompensated and lost pulse briefly -code x 20sec-1min before returning pulse.Original intended procedure was humidification for travel to radiology procedure.Other information about the patient that may have influenced the outcome of the event: multiple factors -patient recently had rvad removed and was on aerosolized veletri (not delivering with filter in line) so climbing pa pressures could be attributed to either.Variable tidal volumes on psv.Was on a dilaudid drip and treated for pain and hour prior to event.

• Brand Name: ULTIPOR 25 ANESTHESIA BREATHING CIRCUIT SYSTEM FILTER
• Type of Device: BREATHING FILTER
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park drive; port washington NY 11050
• Manufacturer (Section G): PALL NEWQUAY; st. columb major ind east; st. columb major; cornwall, TR9 6 TT; UK TR9 6TT
• Manufacturer Contact: brian goetz ; 100 results way; marlborough, MA 01752 ; 5163104370
• MDR Report Key: 18374239
• MDR Text Key: 331119154
• Report Number: 9680602-2023-00001
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BB25AB
• Device Catalogue Number: BB25AB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White