MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-25 for ICY FEMORAL CATHETER 3893 manufactured by Zoll Circulation, Inc..
[19998004]
Customer reported that "central line associated blood stream infection on 3 separate occasions". Event 3: it was reported that on (b)(6) 2012, icy femoral catheter was placed for a cardiac arrest patient. The catheter was removed on (b)(6) /2012 due to patient's increase in temperature. Icy catheter's tip was cultured, staph aureus bacteria was identified. Patient expired on (b)(6) 2012. Event 1: mfr report# 3003793491-2013-00033, event 1: mfr report# 3003793491-2013-00034, event 1: mfr report# 3003793491-2013-00035.
Patient Sequence No: 1, Text Type: D, B5
[20171088]
Zoll medical corporation has not yet received the device. A supplemental report will be submitted if the device is received and when it is evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003793491-2013-00035 |
| MDR Report Key | 2977840 |
| Report Source | 05 |
| Date Received | 2013-01-25 |
| Date of Report | 2012-10-18 |
| Date of Event | 2012-08-24 |
| Date Mfgr Received | 2012-10-18 |
| Date Added to Maude | 2013-04-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CHIBBARO |
| Manufacturer Street | 650 ALMANOR AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4084192955 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICY FEMORAL CATHETER 3893 |
| Generic Name | FEMORAL CATHETER |
| Product Code | LFK |
| Date Received | 2013-01-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION, INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-25 |