MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-06 for ZOLL IVTM SOLEX CATHETER SL-2593 8700-0793-01 manufactured by Zoll Circulation.
[188229839]
Zoll has not received the product for investigation. A follow-up report will be submitted when the product is returned and investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[188229840]
The thermogard ivtm system was used to treat a patient who required mild hypothermia for refractory intracranial pressure (icp). The solex 7 catheter (lot # unknown) was smoothly placed into the patient's left jugular vein, and an arterial catheter was placed for medical reasons. After about 8 hours, during the cooling phase, the thermogard ivtm system alarmed and displayed an "air trap" message. Leak check was performed, and there were no traces of fluid on the floor, on the thermogard console, or on the patient's bed. The user replaced the saline bag to clear the alarm, and the treatment continued. However, after about 8 hours, the thermogard ivtm system generated "air trap" alarm again. Catheter leak and infusion of 500 milliliters of saline were suspected. The catheter was removed without any issues. There was no device malfunction on the thermogard console; however, the treatment was completed using an alternative method. No consequences or impact to patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00226 |
| MDR Report Key | 9802931 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KIM THOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4192922 |
| Manufacturer G1 | ZOLL CIRCULATION |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOLL IVTM SOLEX CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | NCX |
| Date Received | 2020-03-06 |
| Model Number | SL-2593 |
| Catalog Number | 8700-0793-01 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION |
| Manufacturer Address | 2000 RINGWOOD AVE. SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |