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

Model Number 831F75P

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 314001206
• Report Number: 2015691-2023-12431
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: (01)00690103003031(17)230707(11)210707(10)63851213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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
• Patient Outcome(s): Other