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 2020-03-11 for ZOLL IVTM QUATTRO CATHETER IC-4593 8700-0783-01 manufactured by Zoll Circulation.
[188219964]
The quatrro catheter associated with this complaint was not returned for evaluation. The customer disposed the catheter. Since the device was not returned, an investigation could not be performed and a root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[188219965]
After 24 hours of ivtm therapy for hypothermia, the facility's register nurse reported that the thermogard ivtm system generated "air trap" alarm and hospital staff noticed the 500 ml. Saline bag had emptied. The staff checked the tubings and around the thermogard system for fluid leak and did not observed fluid. Staff placed another 500 ml. Saline bag and apparently appeared to be running well, however; the following morning, staff noticed the saline bag had emptied again and the patient wasn't reaching target. Ivtm therapy was discontinued because the patient woke up. Staff removed the quattro catheter (lot #unknown) and disposed it, only the start-up kit (lot #unknown) was saved. The thermogard ivtm system has no malfunction and it is currently in clinical use. Per user, there was no adverse impact on patient due to saline infusion. No consequences or impact to patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00255 |
| MDR Report Key | 9819122 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-15 |
| Date Added to Maude | 2020-03-11 |
| 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 QUATTRO CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | NCX |
| Date Received | 2020-03-11 |
| Model Number | IC-4593 |
| Catalog Number | 8700-0783-01 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-11 |