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 LR CAPILLARY DIALYZER POLYFLUX 6 LR 104333 manufactured by Gambro Dialysatoren Gmbh.
[921058]
The customer complains about blood leak during treatment. There was insignificant blood loss. No medical intervention was needed. No serious injury.
Patient Sequence No: 1, Text Type: D, B5
[8197447]
Internal blood leaks can occur due to damage to the hollow fibres. The sample has not arrived for investigation yet. The root cause can be determined after investigation. Gambro does not regard the submission of this report as an admission of liability.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611369-2008-00784 |
| MDR Report Key | 1153112 |
| Report Source | 06 |
| Date Received | 2008-09-04 |
| Date of Report | 2008-08-14 |
| Date of Event | 2008-07-29 |
| Date Mfgr Received | 2008-08-14 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2009-02-17 |
| 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 - STR 26 |
| Manufacturer City | HECHINGEN 72379 |
| Manufacturer Country | GM |
| Manufacturer Postal | 72379 |
| Manufacturer Phone | 471170 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLUX LR CAPILLARY DIALYZER |
| Product Code | MSF |
| Date Received | 2008-09-04 |
| Model Number | POLYFLUX 6 LR |
| Catalog Number | 104333 |
| Lot Number | 7-8206-H-01 |
| ID Number | NA |
| Device Expiration Date | 2010-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2008-09-04 |