MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for CO-SET+ DELIVERY SYSTEM (CARDIAC OUTPUT TUBING AND SYRINGE) 93610 manufactured by Edwards Lifesciences.
[75941342]
Patient Sequence No: 1, Text Type: N, H10
[75941343]
Patient had 5 french swan placed in catheter lab and patient was readmitted to pediatric intensive care unit. When attaching the cardiac output tubing, the tubing and syringe cracked twice and were defective. Had to get a 3rd set up for it to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6590277 |
| MDR Report Key | 6590277 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-05-08 |
| Report Date | 2017-05-16 |
| Date Reported to FDA | 2017-05-16 |
| Date Reported to Mfgr | 2017-05-16 |
| Date Added to Maude | 2017-05-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO-SET+ DELIVERY SYSTEM (CARDIAC OUTPUT TUBING AND SYRINGE) |
| Generic Name | CARDIAC OUTPUT UNIT, TUBING AND SYRINGE |
| Product Code | DPW |
| Date Received | 2017-05-25 |
| Catalog Number | 93610 |
| Lot Number | 59966174 |
| Device Expiration Date | 2018-02-01 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-25 |