MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY KIT; PRESEP CATHETER

Model Number X3820SJD

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Unspecified Infection (1930); Shaking/Tremors (2515)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.Invasive procedures involve some patient risks.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.In this case, the clinician commented that care of the insertion site was mostly likely a contributing factor to the development of the patient¿s infection.Under the complications section of the ifu it states: positive catheter-tip cultures resulting from contamination and colonization have been reported, as well as incidences of septic and aseptic vegetation in the right heart.Increased risks of septicemia and bacteremia have been associated with blood sampling, infusion of fluids, and catheter-related thrombosis.Preventive measures should be taken to guard against infection (e.G., use of sterile technique, application of topical antibiotic ointment, changing of sterile dressings as indicated by institutional policy, and disinfecting the injection caps before entry with syringe needle) as well as the frequent assessment of the continued need for hemodynamic monitoring.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 a catheter-related infection was confirmed with a presep oximetry catheter after 12 days of use.Reportedly, the catheter was used during total pancreatectomy preserving the splenic artery and vein via laparotomy for pancreatic head carcinoma in a (b)(6) male patient with a history of crohn's disease.The catheter was inserted via right internal jugular vein after general anesthesia.The catheter remained placed in the patient after surgery for total parenteral nutrition (tpn).The catheter was secured using suture loop and/or box clamp.On the 12th day of use, the patient suddenly developed shaking chills followed by a high fever of 40 degrees c.On the same day, samples were obtained from the catheter tip and blood cultures and staphylococcus epidermidis was detected from the both culture results.The catheter was removed.The patient was given antibiotics: tazopip (tazobactam, piperacillin hydrate) and cubicin (daptomycin).The event resulted in extension of hospitalization.The patient's outcome was reported as ¿recovered¿.The customer commented that the event was likely to be a retrograde infection rather than the infection due to procedural factors of catheter insertion, since the duration of the catheter placement was relatively long.

Manufacturer Narrative

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

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8487511
• MDR Text Key: 141166937
• Report Number: 2015691-2019-01199
• 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
• Report Date: 03/13/2019
• 2 Devices were Involved in the Event: 1 2

2 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: X3820SJD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 54