MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-09-04 for POLYFLUX R CAPILLARY DIALYZER POLYFLUX 17 R 109071 manufactured by Gambro Diaylzatoren Gmbh.
[18223905]
The customer complains about blood leak during treatment. The blood flow rate was 80ml/min, tmp, 90mhg. There was insignificant blood loss. No medical intervention was needed. No serious injury.
Patient Sequence No: 1, Text Type: D, B5
[18385850]
Internal blood leaks can occur due to damage of the hollow fibres. No sample is available for investigation. No further info is expected for this specific event and the case is considered closed. The root cause of this event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611369-2008-00813 |
| MDR Report Key | 1153145 |
| Report Source | 06 |
| Date Received | 2008-09-04 |
| Date of Report | 2008-08-18 |
| Date of Event | 2008-08-14 |
| Date Mfgr Received | 2008-08-18 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2009-02-23 |
| 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 | THOMAS KRESPACH |
| Manufacturer Street | HOLGER - CRAFOORD - STRASSE 26 |
| Manufacturer City | HECHINGEN 72379 |
| Manufacturer Country | GM |
| Manufacturer Postal | 72379 |
| Manufacturer Phone | 47117-0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLUX R CAPILLARY DIALYZER |
| Product Code | MSF |
| Date Received | 2008-09-04 |
| Model Number | POLYFLUX 17 R |
| Catalog Number | 109071 |
| Lot Number | 8-3552-H-01 |
| ID Number | NA |
| Device Expiration Date | 2011-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO DIAYLZATOREN GMBH |
| Manufacturer Address | HOLGER - CRAFOORD - STRASSE 26 HECHINGEN 72379 GM 72379 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-04 |