MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-03-13 for PRESSURE MONITORING KIT VO1447TQPL01 manufactured by Edwards Lifesciences Dr.
[102353939]
One quad flothru dpt-vamp flex kit with an iv set and pressure tubing were returned for examination. The reported event of arterial pressure measurement issue was not confirmed. The dpts zeroed and sensed pressure accurately on a pressure monitor. Electrical testing showed that the dpts electronic components were intact because both input and output impedance were within specifications. Zero-offset also met specification. No visible defect was found from the dpt cable connectors. The pressure of the dpt on the arterial line did not show any drift during output drift testing. The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing. There was no evidence of a manufacturing nonconformance. No further actions will be taken at this time. A supplemental report will be forthcoming with the device history results. Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks. The assembly may be tested for dynamic response by observing the pressure waveform on a monitor. Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated. A square-wave test may be performed by pulling the snap tab device and releasing quickly. Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system. Pressure readings should correlate with the patient? S clinical manifestations. It is not known if user or procedural factors may have contributed to the 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
[102353940]
It was reported that during use of a disposable pressure transducer (dpt), the arterial pressure value indicated on the monitor was 20mmhg lower than the expected value during use. It is unknown if the value and waveform matched. There was no information provided on whether the patient was treated based on the incorrect value. The kit was exchanged and the problem was solved. There were no patient complications reported. Patient demographic information requested but unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-00881 |
| MDR Report Key | 7336671 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-03-22 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2018-03-13 |
| 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 SELAWSKI |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES DR |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSURE MONITORING KIT |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2018-03-13 |
| Returned To Mfg | 2018-03-06 |
| Model Number | VO1447TQPL01 |
| Lot Number | JH1049MT |
| Device Expiration Date | 2019-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES DR |
| Manufacturer Address | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-13 |