MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT

Model Number PXVMP172

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problem Burn(s) (1757)

Event Date 03/19/2023

Event Type  Injury  

Event Description

It was reported that during use of a model pxvmp172 pressure monitoring set, the patient was burned during an mri scan.Per the reporter, the patient was brought to mri for an extended scan.The patient was screened, and a ferrous detector wand was used.The lines were set up with the arterial line not touching the patient.During the scan, the device continued to have a good waveform.The patient had been intubated and sedated prior to the scan, so did not complain of pain at any time during the scan.It was not until the scanning was complete that the burn was noticed.It appeared the arterial line had shifted and was touching the left side of the patient arm and the white cable was burned with wire exposed.Per the last customer update, the patient remained stable in the icu with a treatment plan for the burn to be determined by plastic surgery and the wound rn team.The reporter was unable to provide additional information such as what type of burn was sustained, what treatment plan was used to treat the patient, and the overall patient outcome and or prognosis for recovery from the burn.The customer did not have the original packaging, so the lot number is unknown.

Manufacturer Narrative

The product was returned for analysis.Upon completion of the product evaluation, a supplemental report will be sent with the investigation results.The customer was educated on the ifu instructions related to requirements for mri exposure for which the device and cable should never be used and or connected during the mri, including they should not be exposed to the bore of the mri.The lot number was not provided.Therefore, a review of the manufacturing records could not be completed.

Manufacturer Narrative

Our product evaluation lab received one dpt with attached single iv set.As received, the dpt cable was damaged approximately 1 inch from the dpt housing.The damage appeared consistent with a burn mark.The burn area of the cable was approximately 1 inch in length and one of the lead wires was exposed at the burn area.Burn marks were also evident on the iv tubing connector, which was located adjacent to the burn cable area and on the iv tubing, approximately 21 inches proximal from the dpt housing.No other visible damage was observed from the returned kit.It is noted that on (b)(6) 2023, the customer was provided education related to the edwards ifu for pressure monitoring kit model pxvmp172, which instructs that this device and the associated cable should not be used or connected during the mri and are not intended for use inside of the bore of the mri system and should not be in contact with the patient.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

As reported that during an mri a patient from the icu was burned on the left side of the arm by the arterial line cable for the truwave with vamp.The patient was intubated and sedated prior to scanning and was screened and a ferrous detector wand was used prior to scanning.The lines were set up with the arterial line not touching the patient and continued to have a good waveform.However, it was not until the completion of scanning, that it was noticed that the arterial line had shifted and was touching the left side of the arm of the patient, the patient did not complain of pain.The white cable was burned with exposed wire and a treatment plan for the burn was determined by plastic surgery and the wound rn team.The instructions for use caution the user that the truwave pressure monitoring kit with truwave disposable pressure transducer is mr conditional according to the terminology specified in the american society for testing and materials.It is stated that the device and the associated cable are not intended for use inside the bore of the mr system and should not be in contact with the patient.The device and the associated cable may be in the mr system room but not in operation or connected to a pressure monitoring system during an mr examination.Updates to the h6 codes are as follows investigation findings was changed to usage problem identified and investigation conclusions was changed to adverse event related to procedure, cause traced to user, and cause traced to non device related factors.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of a monthly review.No corrective or preventative actions are required at this time.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 16714400
• MDR Text Key: 313044993
• Report Number: 2015691-2023-12242
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PXVMP172
• Device Catalogue Number: PXVMP172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 03/31/2023; 06/16/2023
• Supplement Dates FDA Received: 04/23/2023; 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female