MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.; PHOENIX DISPOSABLE PRESSURE TRANSDUCER

Model Number	VMP306PX
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One single dpt - vamp jr system with attached needless canula was returned for evaluation.Dry blood was visible at tubing to proximal stopcock bond joint of vamp jr system.The reported event of leakage from the connection was confirmed.Leakage was detected at bond joint between the pressure tubing and the proximal stopcock female luer.Red dye solution was manually injected to detect the leak path.Leakage occurred through a channel across bonding area.Tubing od, 0.1085", measured near bond area, was within specification.Mold cavity of the proximal stopcock was a13.No other visible damage was observed from the kit.Udi number for this device is (b)(4).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 a part of the monthly review.
Event or Problem Description
It was reported that while using this vamp jr., there was blood backing up in the tubing and there was leakage from the connection point on the transducer.There was no patient harm, however, there was 1ml of blood loss.The patient was an infant at (b)(6) gest age, (b)(6) grams, (b)(6) day old.There was no procedure being conducted, had just hung iv fluids.Nurse was at bedside at time and reported fluid loss was minimal.Baby did receive a transfusion after event.
Additional Manufacturer Narrative
A device history record review was completed and documented that device met all specifications upon distribution.Even though there was blood backing up in the tube and that the blood loss was minimal from the transducer issue, it was confirmed with the customer, that the blood transfusion was not given because of the issue with the transducer kit.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 a part of the monthly review.
Additional Manufacturer Narrative
A capa was initiated to address this condition to make the solvent bonding process more efficient.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 a part of the monthly review.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.
• Common Device Name: PHOENIX DISPOSABLE PRESSURE TRANSDUCER
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12100867
• Report Number: 2015691-2021-03877
• Device Sequence Number: 4215544
• Product Code: DXO
• UDI-Device Identifier: 07460691950375
• UDI-Public: (01)07460691950375(17)220312(11)201113(10)63445155;(01)57460691950370(17)220312(11)201113(10)63445155
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K925638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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?: Yes
• Device Expiration Date: 03/12/2022
• Device Model Number: VMP306PX
• Device Catalogue Number: VMP306PX
• Device Lot Number: 63445155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• 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: 06/14/2021
• Supplement Date Received by Manufacturer: 07/28/2021; 11/17/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/18/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 1 DA
• Patient Sex: Unknown