MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-12-19 for GAS SAMPLING LINE 73318-HEL manufactured by Ge Healthcare Finland Oy.
[17158647]
The customer reported that the epidural catheter was erroneously connected to the gas sampling line which is a non-sterile fluid path instead of the sterile extension lead of a naropeine syringe. The incorrect connection was noted by the anesthetist and a new autopulsed syringe of naropeine was connected to the epidural catheter. An intravenous antibiotherapy was initiated as to prevent infection. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[17363377]
Under european law and the (b)(6) data protection act 1998, patient information is considered confidential and will not be released by the hospital.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2013-00017 |
| MDR Report Key | 3538708 |
| Report Source | 01,06 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-10-29 |
| Date of Event | 2013-09-20 |
| Date Mfgr Received | 2013-11-20 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2013-12-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer City | HELSINKI |
| Manufacturer Country | FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAS SAMPLING LINE |
| Generic Name | SAMPLING LINE |
| Product Code | CCL |
| Date Received | 2013-12-19 |
| Model Number | 73318-HEL |
| Lot Number | 203008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-19 |