MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ THERMODILUTION VENOUS INFUSION PORT CATHETER; CATHETER, FLOW DIRECTED

Model Number	831F75P
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts were made to secure return of the device however the customer has not responded nor sent the device back for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.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.
Event or Problem Description
It was reported a swan ganz had inaccurate temperature values.Temperature read 35.7 while oral temp read 97.7.Patient have been incorrectly treated with hypothermia.It was noted that the temperature change is used to determine hemodynamic readings.
Additional Manufacturer Narrative
Per additional information from rep, a site visit was conducted at the hospital in response to the reported complaint.Reps spoke to multiple nurses and none were able to confirm that patients incorrectly received hypothermia care for the inaccurate temperature values.Rep checked the oral and pa temperature reading on patients during the visit and all were correlating.When rep asked if their non edwards oral thermometers were calibrated, the nurses were unable to provide an answer.The nurses mentioned that the site had issues with their non edwards cables.Site uses a non edwards monitor.A device history record review was completed and documented that device met all specifications upon distribution.Engineering evaluation was completed, but no findings were available and the cause was not established due to no product return.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 THERMODILUTION VENOUS INFUSION PORT CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16777191
• Report Number: 2015691-2023-12431
• Device Sequence Number: 6986825
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: (01)00690103003031(17)230707(11)210707(10)63851213
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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 Expiration Date: 07/07/2023
• Device Model Number: 831F75P
• Device Catalogue Number: 831F75P
• Device Lot Number: 63851213
• Was Device Available for Evaluation?: No
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown