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 SOLEX 7 CATHETER SL-2593 8700-0793-40 manufactured by Zoll Circulation.
[188149040]
The solex catheter in complaint was returned incompletely. Therefore, functional testing could not be performed. A visual inspection of the returned catheter was performed. Solex catheter was returned without the out luer. The out luered tubing was completely cut off from the distal end of out luer. Observed blood residue on the serpentine balloons. Unable to perform the pressurized functional testing due to the condition in which the catheter was received. 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.
Patient Sequence No: 1, Text Type: N, H10
[188149041]
During the ivtm therapy, the solex 7 catheter was inserted into the right internal jugular vein. The insertion was smooth. Forty-five hours later, and during the 18th hour of the rewarming phase with the patient's temperature at 36. 5? C (target temperature 37? C), the user observed an empty saline bag and the thermogard console generated an air trap alarm. No saline fluid was noted on the patient's bed or under the console. The catheter leak was suspected. No device malfunction was reported for the console. The catheter was not replaced as patient rewarming was completed. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00192 |
| MDR Report Key | 9772403 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2018-10-31 |
| 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 KIMTHOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE, |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| 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 7 CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | NCX |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-11 |
| Model Number | SL-2593 |
| Catalog Number | 8700-0793-40 |
| Lot Number | 87369 |
| 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 |