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 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for product evaluation; but has not yet arrived.When the evaluation findings are available a supplemental submission will be submitted.The device service history record review has been completed and all manufacturing inspections passed with no non-conformances.The mdr submission number for the hem1 instrument involved will be submitted in a supplemental submission.

Event Description

It was reported that the hem1 instrument and swan ganz module were being used for patient monitoring.The values that were displayed did not ¿make sense¿ to the clinician; they did not correlate to the patient¿s condition.The clinician contacted edwards technical support department for help in troubleshooting over the phone.The clinician could not recall if the patient height and weight information had been entered correctly.They were advised to exchange the suspect hem1 unit and sg module and then the appropriate numbers were displayed.There was no inappropriate patient treatment provided.There was no patient harm or injury reported.

Manufacturer Narrative

One swan ganz module was returned for product evaluation.The suspect module was connected to a known good working hem1 instrument for analysis and testing.The cardiac output readings were present and monitored for over one hour.The co readings stayed within appropriate parameters.There were no error messages that were noted.There was no defect found.The reported event was not confirmed by evaluation.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 udi number is (b)(4).The hem1 instrument involved submission number is 2015691-2019-04023.

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: 9255934
• MDR Text Key: 196219626
• Report Number: 2015691-2019-04022
• 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: 10/09/2019

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: 01/31/2024
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 07/23/2020
• Supplement Dates FDA Received: 12/19/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1