MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for VOLUMEVIEW CATHETER VLVUNKNOWN manufactured by Edwards Lifesciences, Pr.
[116712095]
The device was discarded by the customer. Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified. No actions will be taken at this time. The lot number was not provided; therefore, a review of the manufacturing records could not be completed. An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint. The volumeview set, when used in conjunction with the edwards ev1000 clinical platform, is designed for measurement of continuous and intermittent transpulmonary thermodilution (tptd) parameters. The volumeview set enables measurement of intermittent cardiac output (ico) and a range of volumetric parameters including extravascular lung water (evlw) and global end-diastolic volume (gedv). Per the cautions section of the ifu:? Erroneous measurements can be caused by an incorrect catheter position or by electromagnetic disturbance (such as an electric blanket)? Repeat the measurement if the results are implausible.? Volumeview sensor maintenance is required to avoid catheter occlusion and/or avoid inaccurate pressure measurement or cardiac output calculations. Proper volumeview sensor maintenance includes assuring: proper leveling of sensor, pressure bag inflated to 300 mmhg, adequate flush volume, assessment of waveform quality, and periodic assessment of frequency response. The volumeview venous injectate kit setup section of the ifu notes that? Attaching the volumeview venous injectate kit to the central venous catheter is required to obtain volumeview parameters. Per the thermodilution measurement section of the ifu, step 4 instructs to? Select cooled normal saline filled luer lock syringe. Caution: warm injectate may result in inaccurate measurements. Assure timely usage of cooled normal saline filled syringes.? It is unknown whether user or procedural factors contributed to the stated event. 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. Medwatch report number for the associated monitor (ev1000 platform): 2015-2018-03189.
Patient Sequence No: 1, Text Type: N, H10
[116712096]
It was reported that during use of this volumeview set with an ev1000 system, the clinician noted a high evlw (extravascular lung water) value was displayed; however, there was no error message or alarm. The displayed value was 21 ml/kg instead of below 10 ml/kg, as expected per the patient? S status. The patient was not treated based on the inaccurate value provided. There was no allegation of patient injury. Patient demographics were requested but not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-03221 |
| MDR Report Key | 7753873 |
| Date Received | 2018-08-06 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-07-15 |
| Date Mfgr Received | 2018-07-16 |
| Date Added to Maude | 2018-08-06 |
| 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. SAMANTHA EVELEIGH |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| 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 | 0 |
| Brand Name | VOLUMEVIEW CATHETER |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2018-08-06 |
| Model Number | VLVUNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES, PR |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-06 |