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

Model Number PL1012TS_

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/26/2019

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 and device history results when received.

Event Description

It was reported that unknown black particle was observed inside of the pressure tubing of disposable pressure transducer kit before use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The investigation of the particulate in the pressure tubing concluded that a potential root cause could be related to an incorrect extrusion process.Personnel acknowledgement was conducted at infus to prevent recurrence of this type of complaint.

Manufacturer Narrative

One single dpt kit with an iv set and pressure tubing were returned for examination.The reported event of ¿black particle was found inside the pressure tubing¿ was confirmed.One black material was observed inside of the tubing, on the inner tubing wall, at approximately 28.5cm proximal from the male connector, which was connected to stand-alone three-way stopcock.The black material was approximately 0.5mm x less than 0.5mm in size.The material stayed at the same location inside of the pressure tubing after 5 minutes of continuous flushing.The pressure tubing was cut, and the material was found embedded within the inner tubing wall, but a part of the material surface was exposed from the wall.Per chemistry study, the black material could not be identified because of low absorption energy.An engineering investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A review of the manufacturing records indicated that the product met specifications upon release.It is common clinical practice to inspect all products before usage.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.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.In this case, the particulate was noticed before 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.

Manufacturer Narrative

Corrected data: f10, h6.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: 8816922
• MDR Text Key: 154111543
• Report Number: 2015691-2019-02715
• 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,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PL1012TS_
• Device Lot Number: LF0448MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1