MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE PRESSURE CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEMPSC100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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 this monthly review.
Event or Problem Description
As reported, with this hemosphere pressure cable, random and unstable values were provided (medwatch # (b)(4) ).The same cable had presented the same issue with another patient and different nurse (medwatch # (b)(4) ).No further information could be obtained.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
The device was received for evaluation.The report of unstable values was confirmed.Visually, it was detected that the housing was damaged.Besides, the pressure cable connector pins were found pushed in and the cleat was missing.As received, the device was plugged into a known good unit monitor and into the plumsim unit.It was possible to perform the zero waveform and hemodynamic values were obtained.However, after moving the connection between the pressure and the sensor, the values changed while the message was saying , "fault: cable port 1 - pressure waveform not stable" and finally the connection was lost while the message "fault: cable port 1 - pressure sensor" was displayed.Based on further evaluation, the reported issue is related to the damaged pins on the dpt connector that led to unstable values.The connector pin issue is likely related to the handling of the device by the user.No manufacturing related problem could be identified.

• Brand Name: HEMOSPHERE PRESSURE CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19826310
• Report Number: 2015691-2024-05471
• Device Sequence Number: 18316546
• Product Code: DQK
• UDI-Device Identifier: 00690103199321
• UDI-Public: (01)00690103199321(11)200915
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Expiration Date: 09/28/2025
• Device Model Number: HEMPSC100
• Device Lot Number: 14717976
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown