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

Model Number 774F75

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event Description

It was reported that while using this entire hemosphere system, which included the hem1, hemsgm10, hemoxsc100, 70cc2, and swan-ganz catheter, no hemodynamic parameters (including co and svo2) were indicated on the monitor when the patient was transferred from the catheterization laboratory to the hcu and connected to the monitor.The nurse was working on it for an hour, but the problem was not solved.The medical engineer inspected and confirmed that an error message "not calibrated" was displayed on the monitor.Calibration of the svo2 was performed and the cable test was carried out for a disconnection check.After passing the cable test, the 70cc2 cable and hemoxsc cable were reconnected and the co and svo2 values were shown on the monitor.These values, however, were lower than expected and did not fluctuate (the indicated co value: 1-2, svo2: unknown).The target indicators for co and svo2 turned yellow and red.The indicated signal quality index (sqi) level was 1 - normal (hemosphere version 1.1).There was no error message observed at this time.Echocardiography suggested that the values were not affected by the patients condition, therefore, the patient was not treated based on the incorrect values.Since the values shown on the monitor remained low for a while, recalibration and reconnection of the cables were performed.Then the indicated co values became 4-5, which were considered as reasonable values through echocardiography.The svo2 value also appeared to be normal, although the exact value was unknown.These values fluctuated properly, and the measurement was continued.It was confirmed that in-vivo calibration was performed in this case.Measurement data of blood gas analysis was unknown.The indicated value after in vivo calibration was unknown.The percutaneous coronary intervention (pci) was performed, and the patient was on intra-aortic balloon pumping (iabp).When transferring from the catheterization laboratory, the iabp was removed from the patient.The patient was not under hypothermia therapy.Lower limb compression device (covidien kendall scd) was used in this case.The customer commented that they usually used compression device during measurement, but this kind of issue had not occurred before, so they requested to evaluate the devices.There was no patient injury reported.Patient demographics were received.The software logs were requested for evaluation.The swan-ganz cco catheter was used during pci under intra-aortic balloon pump (iabp).The parameters were low or not shown when an intra-aortic balloon pump (iabp) was removed at the end of pci.Although there was no allegation against the cco catheter, the catheter was added since the responsible device could not be determined with available information.The patient was on a foot pump when the issue was observed.The customer had experience of concomitant use of cco catheter and foot pump before without issue; therefore, he suspected the monitor rather than the foot pump.

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without the 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.The lot number was not provided; therefore a review of the manufacturing records could not be completed.Although no fault was found, an investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12861136
• MDR Text Key: 283236362
• Report Number: 2015691-2021-06461
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 68 KG