MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for VOLUME VIEW SET VLV8R416 manufactured by Edwards Lifesciences, Pr.
[138356662]
Our product evaluation laboratory received one image for evaluation. The photo showed the thermistor connector of what appeared to be a femoral catheter. The three pins inside the thermistor connector and the thermistor connector itself appeared intact. It is noted that per the product design drawing, the thermistor connector is supposed to have only three pins. A device history record review was completed and documented that the device met all specifications upon distribution. The customer report of only three pins at the connector making a connection impossible, was not confirmed on evaluation of the provided image. 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. In this case, the patient required a new stick to insert a new catheter. It is unknown if user or procedural factors may have contributed to this 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
[138356663]
It was reported that during use of a volume view sensor, the connector was discovered to only have 3 pins, which made a connection to the ev1000 monitor impossible. An error message was displayed: "no device connected". There was no allegation of patient injury. Demographics were requested and not provided. Unfortunately, the volume view sensor was not available for evaluation due to exposure to a categorized infectious disease; however, the customer provided an image for evaluation. Per additional follow-up with the customer, it was reported that the femoral catheter had to be removed to solve the issue, and the procedure had to be started from the beginning using a new insertion site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00735 |
| MDR Report Key | 8392607 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-01-14 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2018-02-27 |
| Date Added to Maude | 2019-03-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | VOLUME VIEW SET |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2019-03-05 |
| Model Number | VLV8R416 |
| Catalog Number | VLV8R416 |
| Lot Number | 61250014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 |
|---|---|---|---|
| 0 | 0 | 2019-03-05 |