MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; UNKNOWN

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

The product will not be returned for evaluation as the model and lot number are unknown.The exact cable involved is unable to be determined.The device service history record review could not be completed as the serial/lot number is unknown.Edwards is unable to confirm or negate the customer¿s experience without the return of the suspect device.The root cause of the reported issue is indeterminable as the product was not evaluated.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.There was no inappropriate patient treatment administered.With any hemodynamic monitoring, readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.It is unknown if 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 the monthly review.

Event Description

It was reported that the hemosphere swan ganz module provided inaccurate values.The values displayed did not agree with the patient¿s clinical scenario nor with the sv02 values from the swan ganz catheter.The co/ci numbers would drop and then return again.The sg catheter and the cable could not be ruled out as suspect.Another sg module was involved and is suspect.The patient had undergone cabg, mvr and avr with epinephrine and phenylephrine drips infusing, though not high doses.Initially the ci was 0.9.The patient had palpable pulses, adequate output, reasonable filling pressures and bp.The waveforms were normal and the sg catheter position was confirmed on the x-ray.They gave volume and continued to monitor.The ci value fluctuated between 1.5 and 1.2 all day despite increasing the pulse volume and urine output.With good distal pulses and the patient making adequate urine, they expected the ci to be 2.0 and above.That was not the reading they received.There were no error messages displayed.The sqi was 1.They exchanged the sg module and the cable.They did not isolate the issue to either product.They did not exchange the sg catheter as it remained in the patient.They stated that the clinical picture did not explain the values they received.There was no inappropriate patient treatment administered.There was no harm or injury to the patient.The patient demographic information was requested; however, it was not provided.Two sg modules and the sg catheter involved will be reported via mdr as the issue could not be isolated to a product.

Manufacturer Narrative

Please refer to the following mdr submission numbers for the components linked to this event: swan ganz module 2015691-2019-02076 swan ganz module 2015691-2019-02077 swan ganz catheter 2015691-2019-02127.

Manufacturer Narrative

Reference capa-20-00141.

• Type of Device: UNKNOWN
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8680861
• MDR Text Key: 147878232
• Report Number: 2015691-2019-02078
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/07/2019; 07/23/2020
• Supplement Dates FDA Received: 06/21/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1