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

Model Number PXVMP260

Device Problem 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 09/26/2019

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 results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that during use in a patient, the tubing of this disposable pressure transducer (dpt) with vamp had detached from a closed system, while patient was being transferred from the armchair to the bed.It was specified that this disconnection resulted in bleeding however, there was no allegation of patient injury reported.Device was available for evaluation.Patient demographics were unavailable.

Manufacturer Narrative

Further follow up with the customer indicated that the device would not be returned due to infection.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.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.

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: 9312138
• MDR Text Key: 194600382
• Report Number: 2015691-2019-04184
• 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: 10/23/2019

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: PXVMP260
• Device Catalogue Number: PXVMP260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 11/21/2019; 07/23/2020
• Supplement Dates FDA Received: 12/15/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1