MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC HEMOSPHERE; CATHETER, OXIMETER, FIBER-OPTIC

Model Number HEM1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2019

Event Type  malfunction  

Event Description

Placed continuous cardiac output (cco) swan, set up hemosphere then received message "fault cardiac output (co): check thermal filament connection" troubleshooting steps completed and two separate cco cables failed cable test.Called (b)(4) technical support who recommended replacing swan module.No additional swan module available from agiliti and all other hemosphere platforms were in use.Unable to monitor patient as intended.The swan was removed and a new one was placed.Additional information: cco cable lot #s19401, swan ganz module ref: hemsgm10, sn (b)(4), expansion module ref: hemexpm10, sn (b)(4), l-tech expansion module ref: hemltechm10, sn (b)(4).

• Brand Name: HEMOSPHERE
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 9362577
• MDR Text Key: 167600691
• Report Number: 9362577
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2019

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: No Information
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Device Lot Number: S19401
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA