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

Model Number T001744M

Device Problems Leak/Splash (1354); Obstruction of Flow (2423); Device Difficult to Maintain (3134)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

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.In this case a new arterial line was inserted as the arterial line clotted off due to blood backing up in the pressure line.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.It is noted in the ifu that if the flush system is not adequately pressurized relative to the patient¿s blood pressure, blood bleed-back and catheter clotting may occur.An in-serving will be conducted at the hospital to ensure they are using the device as intended/instructed per the directions for use.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

As reported, during use of a disposable pressure transducer with a vamp, blood was observed backing up the tubing even though the pressure bag was at 300mmhg.Clotting was observed and the device was discarded.A new tubing set was used, but clotting was still observed and the arterial line was lost.A new insertion site was used and leakage was observed.It is unknown if additional intervention was performed at this point.Patient demographics were not available due to (b)(6) patient privacy policy.It was confirmed that there was no patient injury.The device was discarded at the hospital.

Manufacturer Narrative

A sales representative visited the hospital do conduct an in-servicing.It was confirmed that the hospital was new to using the pressure monitoring kit.It was also found that the problems experienced by the customer were a result of improper use as the rn¿s did not follow the sop, the dfu or in-servicing directions.The staff was re-trained and additional resources were given for reference whenever there is training any new staff, or hosting a refresher course.At the time of this report there have been no new incidents reported.

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: 8085752
• MDR Text Key: 128287457
• Report Number: 2015691-2018-04766
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• 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: 10/29/2018

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 Expiration Date: 06/28/2020
• Device Model Number: T001744M
• Device Catalogue Number: T001744M
• Device Lot Number: 61422353
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 11/27/2018; 07/23/2020
• Supplement Dates FDA Received: 12/17/2018; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1