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GLOBAL LIFE SCIENCES SOLUTIONS USA LLC. ULTIPOR 100 (BB100A); FILTER, BACTERIAL, BREATHING-CIRCUIT
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| Model Number BB100A |
| Device Problem
Complete Blockage (1094)
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| Patient Problems
Bradycardia (1751); Cardiac Arrest (1762); Diminished Pulse Pressure (2606); Respiratory Arrest (4461)
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| Event Date 01/27/2024 |
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Event Type
Death
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Manufacturer Narrative
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Timeline after receiving copy of the medwatch form via email from the fda.Compliant logged into qms (pall case (b)(4)).Date, action: 2-8-2024, received medwatch form via email from fda 2-9-2024, regulatory and quality leaders informed that medwatch form reporting an adverse event.2-12-2024, (b)(6) medical qa manager sent questions via email to three associates with knowledge of incident (2 associates at (b)(6)) the other at (b)(6) health ((b)(6)) 2-15-2024 (b)(6) medical qa manager sent follow-up email request to all three associates (listed above) with knowledge of incident requesting the answers to the questions sent by email on 2-12-2024.2-19-2024 (b)(6) medical qa manager sent second follow-up email request to all three associates with knowledge of incident requesting the answers to the questions sent by email on 2-12-2024.2-19-2024, a (b)(6) clinical application specialist leader was brought on to the investigation team and placed a call to the director of quality at (b)(6).The call was not answered but a message was left asking for the status of the questions asked in the original email.2-21-2024, (b)(6) clinical application specialist leader spoke with (b)(6) who indicated that he had seen our email, answered all questions he was able to and submitted (them) to their risk management team.(b)(6) said he believed their director of quality would respond to us when they are ready.(b)(6) did not want to go into any details and the conversation did not continue further.2-27-2024, director of quality at (b)(6) has yet to email the (b)(6) medical qa manager or call back the (b)(6) clinical application specialist leader regarding our questions.The following questions were included in the email sent from (b)(6) on 2-12-2024 as part of our investigative process for this incident.Our questions below follow the statements taken from the medwatch form.We provided our interpretation of the statements from the medwatch form (where shown) to help clarify to the associate answering the questions what we believe the statement means to us.Statement from medwatch form: the respiratory therapist (rt) reports that the patient was on a nebulisation treatment on the ventilator.Our questions: what was the patients underlying disease/ reason for being ventilated? did the patient have a cuffed endotracheal tube and have leaks been observed? which alarms had been set on the ventilator during nebulization? which drugs have been nebulized? what was the indication for nebulizing the drug? which kind of nebulizer has been used (wet nebulization, metered dose inhaler,.)? for how long and at which dosage has nebulization been performed? in which position relative to the filter was the nebulizer positioned? for how long has the filter been in place? statement from medwatch form: had just completed the treatment, when she brady' d down to puleslessness.(our interpretation of this statement: the patient's heart rate went down and she lost pulse.) our questions: how was the bradycardia detected? was cardiac monitoring used? statement from medwatch form: rt responded to find the patient difficult to bag.Removed circuit with hme and bagged to trach with no issues.Hme did not appear to be gunked up but would not allow air to flow through.(our interpretation of this statement: apparently the rt made an attempt to switch the patient from mechanical ventilation to a manual resuscitation bag, which was difficult.This indicates that the bb100a was still in place on the patient's endotracheal tube (ett).When the filter and circuit had been removed the rt was able to manually ventilate the patient directly via the ett.) our questions: did the hospital use additional means of airway humidification on the patient? can you provide photos of the filter and/or unused samples from the same lot? if samples of the same lot are available, see shipping instructions below can the hospital also send filters from the same box or take pictures of those? statement from medwatch form: acls performed but patient expired (our interpretation of this statement: advanced cardiac life support was given, but was not successful in reanimating the patient.) our questions: when and how was cardiac arrest detected? at which point in time was acls started (how soon after cardiac arrest)? which measures were taken to resuscitate the patient (drugs, aed,.)?.
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Event Description
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Rt: pt was on a neb treatment on the vent / had just completed the treatment, when she brady' d down to puleslessness.Rt responded to find the patient difficult to bag.Removed circuit with hme and bagged to trach with no issues.Hme did not appear to be gunked up but would not allow air to flow through.Acls performed but patient expired.
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Event Description
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Rt: pt was on a neb treatment on the vent / had just completed the treatment, when she brady' d down to puleslessness.Rt responded to find the patient difficult to bag.Removed circuit with hme and bagged to trach with no issues.Hme did not appear to be gunked up but would not allow air to flow through.Acls performed but patient expired.
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Manufacturer Narrative
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Our company became aware of an event involving a medical device it manufactures and markets from an email it received from the agency's medical device reporting team containing report mw5151114 on 8 february 2024.After a records search, it was determined that no details regarding the event detailed in report mw5151114 were reported to our complaint handling system prior to our receipt of the agency's email.After receiving the report, an internal review determined that a medical device report (mdr) and formal investigation was required.As such, complaint case (b)(4) was raised in our system as per our documented procedures.As part of our investigative process for this incident, we sent an email to the recipients noted below on 12 february 2024 that contained follow up questions about the event.This email was sent by the cytiva medical qa manager to the director of quality at (b)(6) hospital, the respiratory therapist at (b)(6) health and the area director at (b)(6) healthcare, each of whom were thought to have knowledge of the incident.None of the questions were answered despite five (5) follow up attempts made by cytiva associates after the first email was sent.Two of the follow up attempts were made via an email sent to all three of the original email recipients.One (1) follow up attempt was made via phone message to the director of quality at (b)(6) hospital.All attempts of contact were unanswered until the cytiva clinical application specialist leader was informed by the area director of (b)(6) healthcare by phone that our questions were received, however no further responses were received.Our questions are repeated here for reference: what was the patient's underlying disease/ reason for being ventilated? did the patient have a cuffed endotracheal tube and have leaks been observed? which alarms had been set on the ventilator during nebulization? which drugs have been nebulized? what was the indication for nebulizing the drug? which kind of nebulizer has been used (wet nebulization, metered dose inhaler)? for how long and at which dosage has nebulization been performed? in which position relative to the filter was the nebulizer positioned? for how long has the filter been in place? how was the bradycardia detected? was cardiac monitoring used? did the hospital use additional means of airway humidification on the patient? can you provide photos of the filter and/or unused samples from the same lot? if samples of the same lot are available, see shipping instructions below can the hospital also send filters from the same box or take pictures of those? when and how was cardiac arrest detected? at which point in time was acls started (how soon after cardiac arrest)? which measures were taken to resuscitate the patient (drugs, aed)? investigation details: a batch record review for the reported lot number of the implicated breathing filter was completed with no anomalies being observed during device manufacture.An historical review of the complaint database indicated that no recent reports were made for the same type of performance complaint.The last recorded complaint for a similar complaint of device performance was 2020.The complaint recorded in 2020 did not necessitate a remedial action to prevent an unreasonable risk of harm to public health and that no serious injury or death had occurred as a result of the device performance.Despite a request to the customer/end user, no unused samples from the same lot or photographs of the implicated device were sent back to the manufacturing site for further analysis.The customer's complaint of filter occlusion cannot be confirmed without physical examination of the implicated device.A physical walk through of the manufacturing area confirmed that all required procedures were readily available and being followed by the device assembly team.A detailed review of the manufacturing procedures confirmed that the procedures were concise, did not contain ambiguous content and were deemed sufficient without the need for update for clarity purposes.An assessment of the instruction for use, printed on the unit packaging of the breathing filter confirmed that it adequately details how nebulization should be applied (when applicable) during use of the breathing filter.Summary: in conclusion, based on our investigation, it was determined that the implicated product could not be the sole cause for the reported event.The reduction in flow in the implicated filter is likely 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.Since there has been no further information provided by the end users with more detailed knowledge of the incident that was covered in the medwatch report, 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.
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