MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-05 for PRESEP CENTRAL VENOUS OXIMETRY KIT X3820SJD manufactured by Edwards Lifesciences.
[141100892]
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 most 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.
Patient Sequence No: 1, Text Type: N, H10
[141100893]
It was reported that a catheter-related infection was confirmed during use with a presep oximetry catheter after 15 days of use. Reportedly, the catheter was used during a pancreatoduodenectomy laparotomy for pancreas tumor in a (b)(6) male patient with a history of hypertension. 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 15th day of use, the patient suddenly developed shaking chills followed by a high fever of 39 degrees c. On the same day, samples were obtained from the catheter tip and blood cultures and staphylococcus epidermidis was detected from both culture results. The catheter was removed. The patient was given antibiotics: tazopip and sulacillin. The event resulted in extension of hospitalization but the patient's outcome was reported as? Recovered?. The clinician stated 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01200 |
| MDR Report Key | 8487531 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LYNN THOMAS |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES, PR |
| Manufacturer Street | STATE RD INDUS PK 402 KM 1.4 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESEP CENTRAL VENOUS OXIMETRY KIT |
| Generic Name | PRESEP CATHETER |
| Product Code | DQE |
| Date Received | 2019-04-05 |
| Model Number | X3820SJD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-04-05 |