MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-02 for RENAL DIALYZER FK 2008K * manufactured by Fresenius Medical Care North America.
[295632]
A venous line of a crrt (continuous renal replacement therapy) machine became disconnected. The pt had a large volume of blood loss followed by code 300 and death.
Patient Sequence No: 1, Text Type: D, B5
[335560]
Add'l info rec'd from mfr 03/19/04: crrt (continuous renal replacement therapy) was started at 2:00 pm. Blood flow rate was 200 and venous pressure (vp) was 120 and dropped to 100 during the course of dialysis. The vp alarm limits selected was unknown. The pt was awake but had been sedated. At around 8:00 pm the pt's blood pressure dropped. When the nurse checked the pt, she noticed that the venous line had separated from the catheter. There was an arterial pressure alarm but no venous pressure alarm. The vp reading at the time of the incident was unknown. The last documented vp reading was 100. There was a large blood loss but the amount could not be estimated. Code was called but the pt expired. The machine was checked by the hospital bio-med and there was no problem found. It alarmed appropriately when the venous alarm limits were violated. The machine was also checked by a fresenius equipment specialist and was found to be functioning properly. The report indicated that there was a large amount of blood loss. No autopsy was performed and the priamry cause of death was not stated. The device investigation was performed (by fresenius) with the machine in crrt mode. It was noted that the venous pressure alarm limits were set to "user selectable" and the venous alarm width was set at 200. The alarm tests passed. Arterial and venous pressure calibrations were verified. The alarm functions were verified. The machine responded appropriately (visual and audible alarms occurred, blood pump stopped and venous line clamp closed) when the upper and lower venous pressure limits were violated. It was also verified that with blood sensed simulated, the lower venous alarm limit did not go below 0. The device labeling provides a choice of alarm settings. The facility determines which alarm width is set during machine installation. One of the changes made with the fresenius 2008k software version 3. 12 is the default asymmetric venous limits which is included in the software desacription (p/n 507490 rev d). The operator's manual includes a warning regarding pressure changes that may be too small for the system to detect and instructs the user to secure connections properly and to check them regularly. Ansi/aami rd5:2003 also references keshavish, et al (1980) on the serious risk of line separations that may not cause marked decrease in the blood circuit pressure. The mfr believes that the device labeling and the reference stated above are insufficient in educating dialysis providers regarding this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 508952 |
| MDR Report Key | 508952 |
| Date Received | 2004-02-02 |
| Date of Report | 2004-01-16 |
| Date of Event | 2004-01-02 |
| Report Date | 2004-01-16 |
| Date Reported to FDA | 2004-01-16 |
| Date Added to Maude | 2004-02-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENAL DIALYZER FK |
| Generic Name | RENAL DIALYZER |
| Product Code | FIL |
| Date Received | 2004-02-02 |
| Model Number | 2008K |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 497902 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | 2637 SHADELANDS DR WALNUT CREEK CA 94598 US |
| Baseline Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Baseline Generic Name | HEMODIALYSIS MACHINE |
| Baseline Model No | 2008K |
| Baseline Catalog No | F002-40 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K994267 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-02-02 |