MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-27 for POLYFLUX 24R POLYFLUX 24 R 104324 manufactured by Gambro Dialysatoren Gmbh.
[3921425]
A patient with known coronary artery disease and previous acute coronary syndrome coded during the dialysis treatment. Resuscitative efforts were unsuccessful and the patient expired. The patient's family declined an autopsy. The reported cause of death was "acute cardiac event". The clinical coordinator stated there was nothing to indicate any gambro product caused or contributed to the patient's event. The phoenix machine was inspected and performed per manufacturer's specifications. The cartridge blood tubing set, dialyzer and bicart were discarded and not available for investigation.
Patient Sequence No: 1, Text Type: D, B5
[11172698]
The polyflux 24r involved in this incident was not available for investigation and the lot number could not be provided by the facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611369-2013-00006 |
| MDR Report Key | 3373280 |
| Report Source | 05 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-09-03 |
| Date of Event | 2013-09-02 |
| Date Facility Aware | 2013-09-03 |
| Report Date | 2013-09-27 |
| Date Reported to FDA | 2013-09-27 |
| Date Reported to Mfgr | 2013-09-03 |
| Date Mfgr Received | 2013-09-03 |
| Date Added to Maude | 2013-09-27 |
| 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 | THOMAS KRESPACH |
| Manufacturer Street | HOLGER-CRAFOORD-STR. 26 |
| Manufacturer City | HECHINGEN |
| Manufacturer Country | GM |
| Manufacturer Phone | 7471171357 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLUX 24R |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX |
| Product Code | MSF |
| Date Received | 2013-09-27 |
| Model Number | POLYFLUX 24 R |
| Catalog Number | 104324 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO DIALYSATOREN GMBH |
| Manufacturer Address | HOLGER-CRAFOORD-STR. 26 HECHINGEN 72379 GM 72379 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-09-27 |