MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PRESEP CENTRAL VENOUS OXIMETRY KIT; CATHETER, OXIMETER, FIBER-OPTIC

Model Number	X3820SJD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of a catheter, model x3820sjd, that had medication and saline mixed with blood leak during use.The patient was an adult, and the amount of leakage was small.No blood transfusion nor the prolonged hospitalization was required due to the issue.The customer suspected the catheter being sutured/punctured, but the catheter was removed without any issues.After the removal of the catheter, the customer tried to identify the location of the leakage.All lumens were covered and the catheter was able to be flushed.Leakage was later identified at the optical module connector.No patient injury was reported.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The lot number was not provided thus a device history record will not be reviewed.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 a part of the monthly review.
Additional Manufacturer Narrative
A product evaluation was completed on the returned triple lumen oximetry catheter.The reported event of leakage issue was confirmed.Blood was visible at optical module connector as received.Leakage was detected between distal lumen and optical fiber lumen inside backform.No leakage or occlusion was observed in proximal and medial lumens.No other visible damage/inconsistency was observed from the returned catheter.A cut down of the backform was performed for further evaluation, and a gap was observed inside the backform between distal lumen and optical fiber lumen that could lead internal leakage.The backform was from #5 mold cavity.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A capa was generated to investigate and perform actions regarding the interlumen leakage between distal lumen and optical lumen of presep products.As part of the manufacturing process, 100% of the units go through a dry leak test.The test is performed after the backforming process and in the sub assembly manufacturing process.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20517150
• Report Number: 2015691-2024-08038
• Device Sequence Number: 18356805
• Product Code: DQE
• UDI-Device Identifier: 00690103197488
• UDI-Public: 00690103197488
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown