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

Model Number T434304A

Device Problems Disconnection (1171); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

One dpt with vamp adult kit was returned for examination.The reported event of tubing issue was confirmed.The tubing had been detached from the bond joint with a vamp adult reservoir stopcock.Indications of bonding material were evident on some locations of the reservoir bond surface area and the returned detached pressure tubing.The tubing outer diameter was measured near the point of detachment and was found to be within specification.Dry blood was noted in the stopcock, sampling site and the distal pressure line.No other visible damage was observed from the returned parts.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.It is common clinical practice to inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, they are used in critical care units or ors where patients are closely monitored.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.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 a part of the monthly review.

Event Description

It was reported initially, that this disposable pressure transducer set became unscrewed.There was no allegation of patient injury.The device was available for evaluation.As per follow up on 2nd march, it was clarified that the dpt was separated at the pressure line side.As per follow up on 3rd march, it was clarified that the dpt was used in a tetraplegic patient.After 2 days in use, the pressure line suddenly disconnected from the vamp one-way stopcock connector.There was approximately 10ml of blood loss.Patient demographics are unavailable.

Manufacturer Narrative

The investigation of pressure tubing concluded that a potential root cause could be related to an incorrect solvent bonding execution during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 9862939
• MDR Text Key: 194015940
• Report Number: 2015691-2020-11078
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

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: 06/11/2021
• Device Model Number: T434304A
• Device Lot Number: 62286175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 04/21/2020; 07/23/2020
• Supplement Dates FDA Received: 05/08/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1