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

Model Number PX260

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

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

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that during use in a premature baby (27 weeks 6 days), with a disposable pressure transducer that was infused with heparin solution, it was observed that after few hours, all solution was infused into the patient.An x-ray was performed and lasix iv (furosamide) drug was prescribed.In addition, a new solution was prepared and the pressurized bag was changed, however the solution flow in the patient was still too fast.After closing the flow, it was noted that it was still dripping.Therefore the transducer was replaced and a standard drip was obtained.There was no allegation of patient injury.The product was available for evaluation.

Manufacturer Narrative

After further investigation with the user, it was stated that the weight of the baby was 950gr.In addition, it was confirmed that the heparin solution consisted of 250ml of 0.9% saline solution with 0.1ml of heparin, and this was the amount of heparin solution that was in the infusion bag initially.Furthermore, it was confirmed that an infusion pump was not used and only the px260 with a pressure bag was used.It was also mentioned that after the incident a chest x-ray showed a pulmonary infiltration and the baby had to be intubated.Since then the baby showed gradual improvement and was discharged.The product was discarded due to contamination.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.Invasive procedures involve some patient risks.When using a disposable pressure transducer, incorrect flow rates that result in significant unintended fluid delivery poses a risk to the patient.In this instance, the patient was a 950-gram neonate who unintentionally received 250 ml of fluid.The ifu states, ¿to avoid over infusing severely fluid restricted patients such as neonates and children, use an infusion pump in series with the flush device to accurately regulate the minimum amount of flush solution needed to maintain catheter patency while allowing continuous pressure monitoring.Use an iv set that is indicated for use with the iv pump¿¿.It is unknown if user or procedural factors played a part in this event.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.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.

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: 9565727
• MDR Text Key: 194621655
• Report Number: 2015691-2020-10085
• 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,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 61755949
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 WK