MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-10 for ZOLL IVTM ICY CATHETER IC-3893AE 8700-0782-40 manufactured by Zoll Circulation.
[188223629]
The reported complaint of "the icy catheter (lot # 96363) leak" was confirmed during the functional testing. A bonding leak was noticed at the distal end of the distal balloon. The probable root cause for the reported complaint could be due to a latent defect at the bond. Upon visual inspection, no physical damage was observed. Noticed dried blood residue on the catheter balloons and on the in/out luered tubings. During functional testing, all infusion ports and extension tubes were flushed without resistance. The catheter was connected to a pressurized inflation device. Immediately upon pressurizing the catheter, a bond leak was observed at the distal end of the distal balloon. It is unlikely that the defective catheter was shipped. During manufacturing all catheters are 100% inspected for leaks by subjecting them to pressure testing. Only units that passed are moved to the next process. Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for the icy catheter with lot # 96363.
Patient Sequence No: 1, Text Type: N, H10
[188223630]
During ivtm therapy, after 5 hours into the warming mode, the user noticed blood inside the start-up kit (suk) (lot # 097181) tubing. Suspecting icy catheter (lot # 96363) leak. The dwell time of the catheter was 30 hours. The patient's temperature at the beginning of the warming mode was 34? C. The target temperature was 37? C at 0. 25? C rate and the temperature at the time of the issue was 36? C. The catheter was not replaced and no alternate therapy was performed. No device malfunction was reported on the ivtm system. No consequences or impact to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00240 |
| MDR Report Key | 9814067 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-07-01 |
| Date Added to Maude | 2020-03-10 |
| 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 | 2020-03-10 |
| Returned To Mfg | 2020-02-24 |
| Model Number | IC-3893AE |
| Catalog Number | 8700-0782-40 |
| Lot Number | 96363 |
| 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 | 2020-03-10 |