MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-28 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008H NA manufactured by Fresenius Medical Care-north America.
[1897925]
The dialysis clinic reported hemolysis during analysis. Pt was received from post anesthesia care unit, s/p post access surgery. Ten minutes into a hemodialysis treatment, pt became hypotensive and nauseated. Blood was noted to be light in color. Treatment was discontinued. Lab test results showed a hemoglobin of 6. 6, hematocrit of 20 and a potassium of 6. 7. The following day, the physician requested for add'l tests: haptoglobin was 4. 0 and ldh was 359. Dialysate sample drawn showed 3 colonies, but no electrolyte panel was done. Machine passed the tests pre treatment. It was negative for residual disinfectant. There were no blood line kinks noted. The pt received two units of blood.
Patient Sequence No: 1, Text Type: D, B5
[8931822]
(b)(6) - no reported machine problem. Machine investigation showed no problem. There is no info that reasonably suggests that the device may have caused or contributed to the event. Medwatch is being submitted solely due to an adverse event during a hemodialysis treatment. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2011-00002 |
| MDR Report Key | 1977741 |
| Report Source | 05 |
| Date Received | 2011-01-28 |
| Date of Report | 2010-12-29 |
| Date of Event | 2010-12-22 |
| Date Facility Aware | 2010-12-22 |
| Report Date | 2010-12-29 |
| Date Reported to Mfgr | 2010-12-29 |
| Date Mfgr Received | 2010-12-29 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2011-02-07 |
| 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 | 3 |
| Manufacturer Contact | ELVY DIZON, BSN, RN, CNN |
| Manufacturer Street | 2637 SHADELANDS DR. |
| Manufacturer City | WALNUT CREEK CA 94598 |
| Manufacturer Country | US |
| Manufacturer Postal | 94598 |
| Manufacturer Phone | 9252950200 |
| Single Use | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FKP |
| Date Received | 2011-01-28 |
| Model Number | 2008H |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE-NORTH AMERICA |
| Manufacturer Address | WALNUT CREEK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-28 |