MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX272

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Air Embolism (1697)

Event Date 03/18/2023

Event Type  Death  

Event Description

As reported, at the moment of administering the emergency drugs of adrenaline bolus 100 micrograms twice filling with 500 ml lactate ringer and norepinephrine 2 mg/h in continuous infusion in a patient with acute respiratory distress syndrome due to covid pneumonia and influenza a, the pressure monitoring set tubing got disconnected at the level of the stopcock from the edwards central venous line placed at the left subclavian vein.It caused massive air embolism with compromised life prognosis leading to ventilatory difficulties with hypercapnic respiratory acidosis (ph 7.05 pco2 112 mmhg).The patient was immediately transferred to the hyperbaric chamber via emergency medical care service.The device was not available for evaluation.

Manufacturer Narrative

It was further informed that the device was not available for evaluation.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Updated section b2 (outcomes attributed to adverse event), d4 (expiration date), h1 (type of reportable event), h4 (device manufacturer date), h6 (device code(s), h6 (health effect - impact code), h6 (investigation findings) and h6 (investigations conclusions).As per new information received the event description was updated as follows: as reported, this pressure monitoring set tubing (dpt) got disconnected at the level of the stopcock from the central venous line placed at the left subclavian vein.It caused massive air embolism leading to ventilatory difficulties with hypercapnic respiratory acidosis (ph 7.05 pco2 112 mmhg).The patient was immediately transferred to the hyperbaric chamber via emergency medical care service but died few days later.Patient was 57 years old with history of ulcer, diffuse interstitial pneumonia (sarcoidosis) and known idiopathic interstitial pulmonary fibrosis.He had been hospitalized on (b)(6) 2023 in intensive care unit for acute respiratory distress syndrome due to co infection with covid pneumonia and influenza a, that required endotracheal intubation and ventilation.After few days, patient was extubated but still on high-flow nasal oxygen therapy.On (b)(6), when repositioning the patient to half seated position after nursing in laying down position, he lost consciousness with severe bradycardia (30-40 bpm) and severe hypoxemia (spo2 < 20 percent).Immediate cardiopulmonary resuscitation (cpr) was done and the patient was immediately intubated.During cpr when the patient was about to receive epinephrine, it was noticed that the pressure monitoring set was disconnected at the proximal level.The diagnosis of air embolism was confirmed with transthoracic echocardiogram (tte), that also showed bubbles inside the left cavities.The patient was immediately transferred to the hyperbaric chamber.The patient did not recover and passed away few days later.Magnetic resonance imaging (mri) and computerized tomography (ct) scan showed signs of massive encephalopathy.As per customers opinion, considering the bubbles visualized in the left cavities, the patient may have a patent foramen ovale (pfo) that explained the signs of encephalopathy due to cerebral air embolism along with the pulmonary air embolism.After this event, the medical team put in place a severe protocol to check very often all connections of our devices with written traceability.Based on further engineering investigation, the electronic instructions for use (eifu) was reviewed and in the warning section indicates to not to allow air bubbles to enter the setup, especially when monitoring arterial pressures.In addition, in the procedure section indicates to ensure that all connections are secure.Also, in the routine maintenance section it is indicated to periodically check fluid path for air bubbles and to ensure that connecting lines and stopcocks remain tightly fitted.Finally, the complications section indicates: "air emboli.Air can enter the patient through stopcocks that are inadvertently left open, from accidental disconnection of the pressure setup, or from flushing residual air bubbles into the patient".Furthermore, there are manufacturing controls to avoid potential causes related to the reported malfunction.Product risk assessment has been initiated.It was further informed that although the exact lot number could not be clarified, 5 potential lot numbers that were used at the time of the event by the hospital were provided (64570225, 64531179, 64399282, 64539517, 64526600).The manufacturing records were reviewed for the lots potentially involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.1.Lot: 64570225.Manufacturing date: 08/22/2022.Expiration date: 08/21/2024.2.Lot: 64531179.For this lot number, a nonconformance was generated during the manufacturing process; however, is not related to the failure reported.Manufacturing date: 08/09/2022.Expiration date: 08/08/2024.3.Lot: 64399282.Manufacturing date: 05/20/2022.Expiration date:05/19/2024.4.Lot: 64539517.Manufacturing date: 08/12/2022.Expiration date: 08/11/2024.5.Lot: 64526600.Mfg date: 08/01/2022.Exp date: 07/31/2024.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16724366
• MDR Text Key: 313148035
• Report Number: 2015691-2023-12264
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2024
• Device Model Number: PX272
• Device Catalogue Number: PX272
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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): Death; Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 61 KG