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

Model Number 777F8

Device Problem Incorrect Measurement (1383)

Patient Problem Reaction (2414)

Event Date 10/25/2020

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.It is not known if some procedural factors may 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.Please see medwatch number 2015691-2020-14428 for the hemosphere monitor, medwatch number 2015691-2020-14429 for the 70cc2 cable and medwatch number 2015691-2020-14430 for the swan-ganz module.

Event Description

It was reported that during use there were inaccurate values that displayed on the hemosphere instrument.A 70cc2 cable, swan ganz module and swan ganz catheter were involved and could not be ruled out.The patient had a swan ganz catheter inserted to monitor the status of the protamine reaction in the or.The protamine treatment was due to bleeding.There was also increased pa pressure, decreased peripheral blood pressure, decreased 02 consumption, decreased co and a decreased heart rate.The patient was transferred to the icu after the drug reaction.This was at the end of open heart surgery.The swan was connected to the hemosphere instrument in the icu and the patient parameters were co: 1.6, ci: 0.6 and svr upwards of 3300.The clinician believed from the patient's appearance that the numbers should have been reading higher.The patient looked fine and was making urine.They treated the patient because of the protamine reaction and increased epinephrine and decreased the neo synephrine.The swan ganz catheter placement was confirmed by an x-ray and with the pa waveform.During this time it was reported that the sv02 reading was 40 with no sqi bars displayed or alarms present.The co/ci was not alarming to indicate an issue.The next day the flotrac was connected and the parameters did not match with the hemosphere; ft co: 4.5, hs co: 2.7.The clinicians began using the flotrac to treat the patient instead of the sg catheter.The next morning the patient was doing fine.In the evening the patient began to decompensate and passed away.The clinician performed some fick calculations for co, ci and sv and they didn't match the data points with the swan and the hemosphere.They are not alleging that the inaccurate values contributed to the death of the patient.They are reporting the inaccurate values given by the swan ganz catheter and the hemosphere instrument and between the hemosphere and the flotrac.It was later indicated the catheter was discarded at the hospital.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 10856036
• MDR Text Key: 220970712
• Report Number: 2015691-2020-14454
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2020

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: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2020
• Initial Date FDA Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention