MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR BLOOD MANAGEMENT SYSTEM; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VJ0990

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that there was an issue with the z-line, model vj0990.They had a z-line fall apart.The instance happened during a procedure while being used on a patient.This caused blood loss and complete loss of arterial tracing during the procedure.The z-line had to be replaced.They do not know the lot number.The product is available for investigation.

Manufacturer Narrative

Our product evaluation lab received one pressure monitoring line with sample site.Dry blood was visible throughout the line.The customer report of the z-lines fell apart was confirmed.As received, pressure tubing was completely detached from bond joint with sample site.Indication of bonding material was evident on tubing bond surface area.Tubing od, 0.1115 measured near the point of detachment, was within specification.No other visible damaged was observed from the returned unit.Identification of the sample site tubing housing was not able to be measured due to blood residues.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Product risk assessment and capa escalation were not required.As part of the manufacturing process, 100 percent of the units undergo visual inspection, qa sampling pull test, and 100 percent manufacturing flow test is conducted.The investigation indicated that no specific root cause was identified.

• Brand Name: BLOOD MANAGEMENT SYSTEM
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 18647383
• MDR Text Key: 336055271
• Report Number: 2015691-2024-00788
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VJ0990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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