MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PXVJ0711

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

One single dpt - vamp jr kit with attached non-edwards tubing and 10cc syringe was returned for examination.Issue with the returned device was unknown.As received, the pressure tubing was found broken from the bond joint with a shut-off valve of the vamp system.Cross surfaces of the broken tubing appeared rough and uneven.The broken tubing was bent at the site of damage.No other damage was observed from the rest of the kit.The plunger of the vamp system moved within the reservoir without any problem.The dpt zeroed and sense pressure accurately on a pressure monitor.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.Medication not being delivered consistently could cause a deterioration in the patient¿s condition and may necessitate additional interventions.It is unknown whether user or procedural factors contributed to the stated event.In this case, there were no patient complications noted.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.(b)(4).

Event Description

It was reported that the rn noticed leaks from the tubing while performing regular duties, and saw total parenteral nutrition (tpn) on the bed sheets.When flushed, the leak was noticed coming from the vamp jr tubing.No patient complications were reported.The patient demographics are unknown.Attempts are being made with the customer for additional information.Edwards lifesciences was informed of this event through a (b)(4) report.

Manufacturer Narrative

It was concluded that the possible cause for leakage from pressure tubing could be associated to the inadequate execution of solvent bonding process (human error).There are procedures in place for proper execution of the solvent bonding process.The manufacturing personnel was notified of this complaint.However, the condition will continue being monitored through the complaint system and under an existing pra (product risk assessment) created for this issue.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

The udi number for this complaint 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.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; parque industrial de itabo; carr. sanchez km 18.5; irvine ; DR
• MDR Report Key: 9917826
• MDR Text Key: 187412045
• Report Number: 2015691-2020-11290
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2020

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: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: PXVJ0711
• Device Catalogue Number: PXVJ0711
• Device Lot Number: 62429524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 05/29/2020; 07/23/2020; 06/30/2021
• Supplement Dates FDA Received: 06/01/2020; 01/09/2021; 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1