MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ TRUE SIZE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	831F75
Medical Device Problem Codes	Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was blood in the thermistor connection.The rn was called to bedside to possibly attempt additional troubleshooting.Per rn, the accepting rn had noticed that thermistor line on pac had blood on the end upon arrival from cvor & thermodilution was very variable in terms of temperature fluctuation, which was witnessed by multiple staff.Per the clinician thermodilution measurements were variable since arrival in cvicu.The problem was an unsteady baseline temperature introducing noise into the signal for temperature deflection with cold saline injection.When changing the thermistor cable to troubleshoot earlier in the pm, blood was noted in the thermistor connector.This was initially thought to have resulted from external contamination.However, upon closer inspection it appeared that blood-tinged fluid may have been leaking from the small hole in the thermistor connector.Catheter was discontinued and rn retained in a biohazard bag.No allegation of patient injury.
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.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
The device was not returned therefore no evaluation could be performed since no objective evidence such as product samples, imagery, or videos was provided for investigation.As such, based on available information, a definite root cause is unable to be determined at this time.As part of the manufacturing process 100% of the units go through a leak and flow test, a balloon inspection, a lumen inspection, and an electrical inspection.The lot number was not provided thus a device history record was not 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.

• Brand Name: SWAN-GANZ TRUE SIZE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20623656
• Report Number: 2015691-2024-08382
• Device Sequence Number: 21051227
• Product Code: DQO
• UDI-Device Identifier: 00690103000245
• UDI-Public: 00690103000245
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K810352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: 831F75
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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