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

Model Number PX12N

Device Problems Fluid/Blood Leak (1250); Difficult to Flush (1251); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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.Lot number was not provided; therefore review of the manufacturing records could not be completed.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.Since these devices are indicated for pediatric patients, whose blood volume is much smaller than an adult, they cannot tolerate blood loss as easily as adults.Consequently, there is potential for patient injury.In this case, there were no patient complications noted.Any additional finding will be submitted in a supplemental report.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 with a neonate patient, the arterial line stopped tracing while the syringe pump was infusing saline through the umbilical arterial catheter (uac).It was noted that only a small amount of blood with air bubbles could be aspirated during the flushing process.The ¿red bung¿ that connects with the transducer set was changed and the blood aspirated without any air bubbles and no other issue.However, 10 minutes later the tracing disappeared again and a small amount of blood, less than 1 ml, was noted on the patients sheet indicating there was leakage from the ¿transparent hub on the uac.The entire unit including the edwards pressure monitoring kit was sent to vygon (the manufacturer of the umbilical artery catheter) for testing.It was also indicated that vygon has issued an fsca against their white and red bungs.There was no allegation of patient injury and no patient demographics could be obtained.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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: 8134168
• MDR Text Key: 130478416
• Report Number: 2015691-2018-05092
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

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 Model Number: PX12N
• Device Catalogue Number: PX12N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1