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

Model Number T001671A

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.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.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.In this event, there was no patient compromise 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.

Event Description

It was reported that during use of this disposable pressure transducer with a vamp, the pressure tubing disconnection from the vamp.No blood loss was observed.There was no allegation of patient injury reported.The device was discarded at the hospital.The patient demographics were not available.

Manufacturer Narrative

Correction-it was originally reported that the device was discarded.However, the device was not discarded and returned for examination.One vamp adult kit with light blood in the distal male connector and stopcock was returned for examination.The reported event of tubing issue was confirmed.The pressure tubing detached from the bond joint with a vamp adult reservoir stopcock.Indications of bonding material was evident on some locations of the reservoir bond surface area and the returned detached pressure tubing.The tubing outer diameter was measured and found to be within specification.No other visible damage was observed from the returned parts.The investigation of this pressure monitoring kit with a vamp adult 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.

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 ; DR
• MDR Report Key: 8271075
• MDR Text Key: 134330535
• Report Number: 2015691-2019-00238
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2020
• Device Model Number: T001671A
• Device Lot Number: 61285325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1