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 2020-03-05 for ZOLL IVTM COOL LINE CATHETER N/A 8700-0781-03 manufactured by Zoll Circulation.
[186586680]
The reported complaint of a leaking cool line catheter (lot #98562) was confirmed during function testing. A pinhole leak was observed at middle distal balloon. The probable cause of the pinhole leak issue was due to a latent material defect. No physical damaged observed on the returned catheter during visual inspection. Blood residue was observed on balloons, medial and proximal luered tubings. Functional testing of the returned catheter was performed. All infusion ports and extension tubes were flushed without resistance. In addition, the catheter was connected to a pressurized inflation device. Immediately upon pressurizing the catheter, a pinhole leak was observed at middle distal balloon. Thus, confirming the reported complaint. 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. Therefore, it is unlikely that the catheter was defective when shipped. Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for cool line catheter with lot number 98562.
Patient Sequence No: 1, Text Type: N, H10
[186586681]
On day 4 of ivtm therapy, the customer observed pink-colored saline fluid in the start-up kit (suk) tubing and decreasing saline fluid volume in the saline bag. No saline fluid leak was observed on the suk. Leaking cool line catheter (lot #98562) suspected. The physician temporarily discontinued the ivtm therapy since the patient's temperature was stable. No consequences or impact to patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00222 |
| MDR Report Key | 9793655 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-02-09 |
| Device Manufacturer Date | 2019-09-13 |
| Date Added to Maude | 2020-03-05 |
| 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 COOL LINE CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | NCX |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-02-24 |
| Model Number | N/A |
| Catalog Number | 8700-0781-03 |
| Lot Number | 98562 |
| 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 | 2020-03-05 |