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

Model Number PX284

Device Problems Excess Flow or Over-Infusion (1311); Leak/Splash (1354)

Patient Problems Overdose (1988); No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

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 during use of a pressure monitoring kit, 500cc of ns (normal saline) from the pressure bag infused into an adult patient.A proper waveform was observed when the nurse left the patient¿s room.When the nurse retuned an hour later, the ns bag was empty.The pressure bag was not over inflated and there was no visible fluid on the bed or the floor.The pressure monitoring system was replaced.The patient was not known to be on any type of fluid restriction.Patient demographics were unable to be obtained.There were no patient complications.Detailed demographic information not available at this time.

Manufacturer Narrative

One single dpt kit with attached empty 500 ml iv bag was returned for examination.The reported event of iv bag was empty within one hour was not confirmed.The returned pressure monitoring kit was primed and flushed without any indication of occlusion or flow restriction.No leakage was detected from the kit during a leak test.The flow rate was tested and found to be within specification.A review of the manufacturing records indicated that the product met specifications upon release.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to use the system, to consider the potential benefits in relation to the possible complications.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.In this case it was noted that there was no patient compromise.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.

Manufacturer Narrative

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: 8997092
• MDR Text Key: 198710030
• Report Number: 2015691-2019-03396
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2019

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: PX284
• Device Catalogue Number: PX284
• Device Lot Number: 62151193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 09/16/2019; 07/23/2020
• Supplement Dates FDA Received: 09/30/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1