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); Output Problem (3005)

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

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

The swan ganz module will not be returned for evaluation as the exact device that was used could not be identified.A serial number cannot be provided.There is no product return.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.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 service history record review could not be completed as the serial number is unknown.The sg catheter submission number is 2015691-2019-02901.

Event Description

It was reported that there was inaccurate values while using the hem1 monitor, sg module and 70cc2 cable with a swan ganz catheter.The hospital rn stated that there was a sick emergent heart patient with good pulses and with good urine output.The cardiac index was 0.9 to 1.4 during patient monitoring.There is limited information available on the event.Patient demographic information is not available.The issue was not able to be isolated to a product.All products involved will be under a separate submission number.The submission numbers will be provided when available.There was no patient harm or injury reported.There was no inappropriate patient treatment reported.

Manufacturer Narrative

The submission numbers of the other products involved in this event: swan ganz catheter 2015691-2019-02901.70cc2 cable 2015691-2019-02972.Hem1 instrument 2015691-2019-02944.

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: 8880985
• MDR Text Key: 154317043
• Report Number: 2015691-2019-02971
• 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: 07/17/2019

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 Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 08/09/2019; 07/23/2020
• Supplement Dates FDA Received: 08/22/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1