MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774F75

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.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.No corrective actions will be taken at this time.Lot number was not provided; therefore, review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications are well described in the literature.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure tubing that is used with swan ganz catheters can also be a contributing factor to inaccurate values.In regards to the pressure tubing used with swan ganz catheters, it should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown whether user or procedural factors contributed to the stated event.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 part of this monthly review.The reference medwatch number for the hemosphere monitor is 2015691-2020-14714 and the medwatch number for the swan module is 2015691-2020-14732.

Event Description

It was reported that during use in a heart transplant patient, unstable co/ci readings were observed on a hemosphere instrument/monitor (hem1), swan ganz module (sgm) and swan ganz catheter.The issue could not be isolated to one of these devices.The readings for cardiac output were up and down between 3.8 to 7.7 within 10 minutes.There were no error messages observed.This was occurring while the patient was sitting in a chair.There was no intervention with drips, fluid, etc.There were no patient complications reported.The patient demographic information was not provided.The exact equipment is unable to be determined; therefore, there is no product return.In addition, the sg catheter involved was discarded by the facility.

Manufacturer Narrative

Further investigation found that after reviewing the information available and the images, that the large variation in sco (stat co) is to be expected in this scenario.When there is thermal stability introduced due to extraneous factors like infusions, positional adjustments, the expectations is that the stat values will react faster.Since it was reported that the patient was sitting up and possibly moving, this movement may add noise to the thermal signal causing the sco values to vary in large steps as the averaging duration for sco is short.Hemosphere provides cco parameter with longer averaging time to average out these large changes seen in sco.In conclusion, this would not be an event related to the catheter malfunctioning.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10922662
• MDR Text Key: 220979758
• Report Number: 2015691-2020-14764
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

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 Operator: Health Professional
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMOSPHERE MONITOR/SWAN-GANZ MODULE.