MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-04-22 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[142785778]
Title collection of peripheral blood stem cells from a (b)(6)-old girl with the use of combined heparin and citrate anticoa gulation source journal of clinical apheresis, volume 28, 2013 (309? 310) date of publication: 24 july 2013. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142785779]
According to literature source of study performed 2013, on a previously healthy girl ((b)(6)) who was diagnosed with stage iv neuroblastoma, a double lumen catheter was placed in the right femoral vein. The plan was to perform apheresis and process a total of four bvs (blood volumes), amounting to 2,100 ml of blood, but, unfortunately, the line stopped working shortly after the start of the procedure despite serial flushing with ns 0. 9%. One mg of alteplase infusion in each lumen was partially successful in restoring the blood flow, and it was possible to process 1. 3 bvs. The following day the line was changed over a guide wire. There was no reporter patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00100 |
| MDR Report Key | 8537901 |
| Report Source | LITERATURE |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2019-04-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALYSIS UNKNOWN |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2019-04-22 |
| Model Number | DIALYSIS UNKNOWN |
| Catalog Number | DIALYSIS UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-22 |