MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN GANZ MODULE

Model Number HEMSGM10

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for analysis.Upon receipt of the product a supplemental report will be submitted with the product evaluation findings.The device service history record review is pending.Once the results are received the results will be submitted in the supplemental report.(b)(4).

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, the hospital will not release it.Another sg module, the sg catheter and the cable involved will be reported via mdr as the issue could not be isolated to a product.

Manufacturer Narrative

One hemosphere swan ganz module was received for product evaluation.It was connected to a known good working hemosphere instrument for testing and analysis.The system verification test was performed.The co values remained within appropriate parameters.There were no faults or error messages noted.A visual external inspection was performed and there was no physical damage identified.There was no defect found.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.The device history record review was completed and all manufacturing inspections passed with no non-conformances.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: HEMOSPHERE SWAN GANZ MODULE
• Type of Device: HEMOSPHERE SWAN GANZ MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8680833
• MDR Text Key: 147878521
• Report Number: 2015691-2019-02076
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• 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: 05/16/2019

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
• Device Expiration Date: 02/08/2024
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 07/23/2020
• Supplement Dates FDA Received: 07/30/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1