MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE PRESSURE CABLE

Model Number	HEMPSC100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for return and the evaluation is anticipated.The complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.The device history record review is pending and the results will be submitted in a supplemental report when available.
Event or Problem Description
It was reported that there were inaccurate blood pressure readings during patient use.The psc100 pressure cable was connected to the hemosphere monitor.The reading on the hemosphere monitor that was sent to the phillips monitor did not match.The nurse noticed the difference immediately.There were no error messages displayed.The displayed numbers and what they were expected to be are unknown.A new cable was exchanged for the suspect cable and it was connected and it resolved the issue.There is no patient injury.There was no inappropriate patient treatment administered.The patient demographics were requested and were not provided.
Additional Manufacturer Narrative
The hemosphere pressure cable was received for product evaluation.The cable was connected to a known good working hemosphere unit for testing.It was tested three separate times and each time it was recognized by the hemosphere without any error messages that displayed.When the cable was connected to a plum simulator, a waveform displayed and was able to be zeroed three times without any issues.A normal mean arterial pressure reading was obtained each time.The cable was moved around during testing and it had no effect on the reading.A visual inspection of the cable found no physical damage.The reported issue was not confirmed.The device history record review was completed and all manufacturing inspections passed with no non-conformances.There was no evidence of a manufacturing non-conformance.It is not known if any procedural factors may have contributed to the 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.

• Brand Name: HEMOSPHERE PRESSURE CABLE
• Common Device Name: PRESSURE CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18673892
• Report Number: 2015691-2024-00882
• Device Sequence Number: 7309272
• Product Code: DQK
• UDI-Device Identifier: 00690103199321
• UDI-Public: (01)00690103199321(11)220120
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: HEMPSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown