MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-10-17 for TRANSCUTANEOUS BLOOD GAS MONITOR TOSCA 92 SENSOR 5621000 manufactured by Radiometer Medical Aps.
[20295172]
The customer contacted radiometer due to a problem with the tcpco2 sensor. Was 5, 2 an the blood sample was 15,4. The radiometer representative re-membraned the sensor and then tcpco2 sensor showed 11, 3 and a blood gas sample was 10, 7. The next day the customer used the sensor for some hours and then suddenly the tcpco2 sensor stopped working. During the re-membraning of the sensor, performed by the radiometer representative it was discovered that the customer, by mistake, had used contact gel instead of electrolyte solution while performing the re-membraning of the sensor. The patient was not adversely affected by this problem.
Patient Sequence No: 1, Text Type: D, B5
[20574070]
This device is intended only as an adjunct in patient assessment and must be used in conjunction with clinical signs and symptoms (operators manual page 1-2). It can thus not be expected that results from the tcm analyzer matches results from a blood sample. This event is suspected to be caused by a user error since the user used contact gel instead of electrolyte solution during re-membraning. This risk was anticipated in the product risk analysis and has been mitigated by color coding of sensors and supplies (the electrolyte solution and contact gel has different colored labels and tops) and by notification of the user in a guide which describe the color code and use of right supplies. While the radiometer representative visited the customer with correct use of these supplies was explained. The sensor in question has been investigated, and the investigation showed that the sensor had a too high response time. This is suspected to be due to the incorrect use of supplies with this sensor. This is currently being confirmed. This event is considered to be a reportable user error and since no product malfunction has been established or is suspected, this event is reported as an adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2014-00046 |
| MDR Report Key | 4185158 |
| Report Source | 01,05 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-09-15 |
| Date Mfgr Received | 2014-09-15 |
| Date Added to Maude | 2014-10-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM 4 TOSCA COMBI M |
| Product Code | LKD |
| Date Received | 2014-10-17 |
| Model Number | TOSCA 92 SENSOR |
| Catalog Number | 5621000 |
| Lot Number | 9234613 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DK-2700 DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-17 |