MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-28 for ZOLL IVTM ICY CATHETER IC-3893AE 8700-0782-40 manufactured by Zoll Circulation.
[186532744]
The reported complaint of icy catheter (lot# 93501) balloon leak was not confirmed during visual inspection and functional testing. No device malfunction was observed. Upon visual inspection, no physical damage was observed on the catheter. The balloons were examined and there were no tears, balloon bond detachment or rupture noted. Observed blood residue on the balloons. During functional pressure leak test, all infusion ports and extension tubes were flushed without resistance. The catheter was connected to a pressurized inflation device, the balloons were fully inflated when pressurized up to 100 psi without any issues. The balloons did not leak during inflation and deflation. No leak was observed. All lumens flushed as intended. The returned icy catheter was connected to the returned suk and run on the peristaltic pump, no leak was observed on the catheter. The returned icy catheter was connected to the returned suk and ran with the thermogard xp ivtm system for an hour in the max warming mode with target temperature of 37? C and an hour in the max cooling mode with target temperature of 35? C, no leak was observed on the catheter. The icy catheter performed as intended.
Patient Sequence No: 1, Text Type: N, H10
[186532745]
After four days of ivtm therapy, the user observed the saline bag was empty. The console did not display an alarm. Upon inspection, no fluids were observed anywhere. Following this, the icy catheter was replaced and completed ivtm therapy. The user suspect on the icy catheter leak. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00191 |
| MDR Report Key | 9772285 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-28 |
| 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 ICY CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | NCX |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-12 |
| Model Number | IC-3893AE |
| Catalog Number | 8700-0782-40 |
| Lot Number | 93501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-28 |