MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PEDIASAT OXIMETRY CATHETER KIT; PEDIASAT CATHETER

Model Number XT3515SJ

Device Problem Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

One triple lumen 5.5f pediasat catheter was returned for evaluation.Non-edwards injection ports were attached at the lumen hubs.Packaging and all other components were not returned.Leakage was detected between the proximal lumen and the medial lumen inside the backform.No leakage or occlusion was observed in the distal lumen.No visible damage to the catheter body was observed.A cut down was performed on the backform.Blood was visible in the proximal lumen.Both the distal and optical extension tubes were found to be inserted 0.402" into the backform and entered the medial and proximal lumens.The lengths of the extension tubes in the backform were found to be out of specification.Visual examinations were performed under microscope at 10x magnification.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of leakage issue was confirmed.A capa has been opened to further investigate the cause of this issue and implement any necessary corrective actions.If a leak in the backform is undetected at routine pre-insertion flushing, the catheter could leak during use and need to be removed/ exchanged for a new one.This could be done over a guidewire with minimal delay in therapy, and would not require a new venous access.These catheters, however, are used in pediatric patients, who have a lower threshold for brief interruptions in therapy or medication administration issues than adult patients.This results in a higher potential for an injury to occur.In this case, a rapid infusion of medication due to an inter-lumen leak changed the pediatric patients vital signs.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

It was reported that leakage was observed using a pediasat catheter on the first day of use.Initially it was unknown where the leakage occurred or what fluid had leaked.Additional information was received that the fluid was catecholamine medication.During infusion of the catecholamine, the physician performed a rapid flush of the opposing lumen and it was assumed that catecholamine was rapidly pushed into the patient due to an inter-lumen leak.The patients vital signs changed after the rapid flush.The patient is of an unknown age, but is an infant or neonate.Further patient demographic information was not available.Patient status could not be confirmed.

Manufacturer Narrative

A more descriptive health effect - impact code was chosen as the patient did not overdose.There was a bolus of medication but no change to dosage.No intervention was required.Follow-up confirmed that there was no patient injury due to the event.

Manufacturer Narrative

Additional information from the reporter indicated that the one-month-old infant received dopamine and bosmin via the medial lumen, nitroglycerin via the distal lumen, and other medication + cvp via the proximal lumen used for a cardiac surgery.The doctor does not remember the exact concentration correctly.When the medication was administered to the patient via the distal lumen, blood pressure elevation was confirmed, but it us unknown how much it was elevated and for how long.Then the customer tried a medication switch between medial and proximal lumen assuming a shunt.The pediasat was connected to the dtp.Operation was completed and the patient was sent to a ward.The customer changed the catheter 3 to 4 days after the operation.It is hospital practice to flush all lumens of the catheter prior to use, but the customer did not see any leak when flushing the pediasat.

• Brand Name: PEDIASAT OXIMETRY CATHETER KIT
• Type of Device: PEDIASAT CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11780568
• MDR Text Key: 252336097
• Report Number: 2015691-2021-02814
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K053609
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XT3515SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 05/13/2021; 06/23/2021
• Supplement Dates FDA Received: 06/03/2021; 07/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 MO