MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VOLUMEVIEW SYSTEM; PROBE, THERMODILUTION

Model Number VLVCVT5

Device Problem Leak/Splash (1354)

Patient Problem Air Embolism (1697)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

One manifold with stand-alone stopcock device was returned for evaluation.The reported event of manifold broken was confirmed.The luer connection for the central venous catheter of volumeview manifold had been completely broken.The broken male luer was not returned.Cross surface of the broken luer was rough and uneven.No other visible damage was observed from returned unit.Further investigation has been assigned for any manufacturing related non-conformance's.A device history record review was completed and documented that device met all specifications upon distribution.As part of the complaint investigation , an edwards product safety physician traveled to the hospital to discuss the case with the attending physician.Even if the air embolism was clearly identified, it was not possible to determine when this occurred and whether this was the main cause of the desaturation in the context of the other issues the physician had to manage.At the time of the visit, the patient was still hospitalized but stable and has no complications related to this incident.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.

Event Description

As reported, during use in a (b)(6) patient hospitalized in the neuro-intensive care for ruptured aneurysm of the anterior communicating artery, the connection between the volumeview thermistor manifold and the 3-way stopcock of the extension line connected to the central venous catheter broke.The additional 3 way-stopcock that was fixed to the manifold was added by the facility as part of their practice and protocol to prevent infection.The physician was called to the bedside for the patient¿s sudden desaturation to 80%.A breakage at the level of the manifold was noted because of a small amount of blood leakage being noted.The physician aspirated 7 ml of air from the line and felt that this may represent an air embolism.Due to the patient's comorbidities, which are the patient endotracheal tube became malpositioned which resulted in air volume leakage, left lower lobe atelectasis respiratory degradation and ards.The physician could not determine if the air embolism contributed to the desaturation.The patient was treated medically by increasing fio2 to 100% for 6 hours, though it could not be confirmed that the embolism was the cause of the desaturation.The patient recovered from the desaturation episode.

Manufacturer Narrative

As per further information provided the event occurred 3 days post urgent neurosurgery / embolization and external ventricular drain.Patient was still intubated and sedated for refractory intracranial hypertension (sedation with propofol, midazolam, pentothal + analgesic + curarization).It was later updated that the patient was stable from a neurological and hemodynamic point of view.There were no remote clinical consequences associated with the reported incident.

• Brand Name: VOLUMEVIEW SYSTEM
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 10731325
• MDR Text Key: 213046104
• Report Number: 2015691-2020-14126
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K100739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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: 06/23/2022
• Device Model Number: VLVCVT5
• Device Lot Number: 63237775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention