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

Model Number T001691M

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

Patient Problems Exposure to Body Fluids (1745); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as 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.Lot or serial 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.Healthcare personnel are at risk for occupational exposure to blood borne pathogens including (b)(6).Exposures can occur through needle sticks or cuts from other sharp instruments contaminated with an infected patient¿s blood or through contact of the eye nose, mouth or skin with patient¿s blood.Post-exposure treatment may be recommended if it cannot be verified that the patient¿s blood is not infected.In this case the health care providers were started on anti-retroviral treatment because the hospital cannot oblige the patients to complete an infectious blood test.Therefore, it could not be confirmed that there was no risk of infection.The ifu states: ¿always use (b)(4) compliant syringes to avoid potential collapsing of the septum after syringe insertion and removal.Carefully connect the syringe to the lass sampling site by slowly pushing the syringe straight into the site using a clockwise, rotating motion until it is fully seated.Do not try to insert the syringe at an angle.Do not try to pry open the septum¿s slit in the sampling site.The slit automatically opens when the syringe is connected.Do not use excessive force to connect the syringe.Remove syringe from the lass sampling site, rotating counter clockwise.The blood sampling site¿s septum completely closes after each use.¿ it is unknown whether user or procedural factors played a role in this event.An in-service is to be provided to hospital personnel to reiterate the proper use of the lass system.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

While flushing the line using a disposable pressure transducer with lass vamp closed blood sampling system, a resistance was felt at the syringe plunger.Blood leakage of around 1cc at the sampling site was noticed.However, it was later communicated that the nurse received a blood splash in the eye and was put on antiretroviral therapy for precaution.The device was discarded at the hospital.There was no allegation of patient injury.

Manufacturer Narrative

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

• Brand Name: PRESSURE MONITORING SET
• 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: 7749347
• MDR Text Key: 116046676
• Report Number: 2015691-2018-03199
• Device Sequence Number: 0
• Product Code: DXO
• 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: 07/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T001691M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 08/03/2018
• 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
• Patient Outcome(s): Other