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 2018-03-14 for VOLUME VIEW CATHETER VLV8R520 manufactured by Edwards Lifesciences, Pr.
[102454648]
The device was discarded by the customer. Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can a root cause or any potential contributing factors be identified. A device history record review has been initiated to assess that the device met all specifications upon distribution. Upon completion, a supplemental report will be sent with the investigation results. An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint. 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. With any hemodynamic monitoring, temperature readings can change quickly and dramatically. A temperature reading that changes dramatically can be an indication to the user to begin the troubleshooting process before a cardiac output measurement is attempted. The patient? S body temperature by can be obtained by different means and compared to the temperature obtained from the catheter. If they do not correlate to the clinician? S satisfaction, it is common clinical practice to the abort the attempt to obtain cardiac output. The catheter can be exchanged if desired. 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.
Patient Sequence No: 1, Text Type: N, H10
[102454649]
It was reported that during use of a volume view set, the temperature values? Jumped? Between 0 to 43? C after completing the bolus injection. The clinician recognized the temperature values as abnormal compared to the patient condition and manual measurement obtained with a digital meter. The patient was not treated based on the temperature values provided and there was no allegation of patient injury. It was noted that all volume view parameters were being measured at the time of the issue; however, only the temperature values were reported as inaccurate. There were no error messages observed. The customer declined to provide patient demographics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-00900 |
| MDR Report Key | 7339881 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-14 |
| Date of Report | 2018-02-19 |
| Date of Event | 2018-02-18 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-03-14 |
| 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 | 3 |
| Brand Name | VOLUME VIEW CATHETER |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2018-03-14 |
| Model Number | VLV8R520 |
| Catalog Number | VLV8R520 |
| Lot Number | 60998517 |
| 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 | 2018-03-14 |