MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-05-18 for FRESENIUS DIALYSIS MACHINE 2008H manufactured by Fresenius Usa.
[17962438]
Corrected/missing data from user facility report: (b)(4) - addressed in device labeling as serious injury; (b)(4) - addressed in device labeling as hypervolemia. (b)(4) - incorrect setup - addressed in device labeling; (b)(4) - addressed in device labeling. Method: corrective action was implemented at the facility prior to the manufacturer's device investigation. Results: a fresenius equipment specialist verified that the implemented corrective action on the machines was done correctly. The machines are now set correctly for the type of concentrate being used. The facility converted from one acid concentrate type (9000 series or 36. 83x) to another type (4000 series or 45x). An equipment technician improperly set the 2008h machine for the respective concentrate type. This operator error prevented the machine from properly proportioning the acid and bicarbonate concentrate. The machine proportions acid and bicarbonate to the final dialysate concentration, based on a defined dilution ratio for the given concentrate type (36. 83x versus 45x). In house testing, by the manufacturer, simulating the operator error showed that improperly setting the machine to another concentrate type could result in a normal dilution of sodium and a bicarbonate concentration that is approx 20% higher than the set value. The 2008h operator's manual warns the operator to "be sure to use compatible concentrate types, labeling and set-ups. These setups include machine calibration, special adapters for certain concentrate types, correct setting of concentrate option, and labeling. Failure to use the properly matched solutions and machine calibrations may allow improper dialysate to be delivered to the pt, resulting in pt injury or death. Verify composition, conductivity, and ph after converting to a different type of concentrate. " "the conversion to other dialysate concentrate types must be done by a qualified, authorized person according to written procedures. " "operator should always check conductivity and approximate ph of the dialysate prior to initiating treatment. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[17977214]
During a dialysate conversion, we discovered on (b)(6) 2009, that the incorrect concentrate family had been chosen when the 2008h machines were re-calibrated, but the machines were running within normal limits. There existed a potential to have exposed pts to incorrect dialysate levels. We reviewed all labs and hospitalizations and found the following events may have been caused or exacerbated by the incorrectly calibrated machines: all pts admitted for fluid overload. Patient a: hospitalized on (b)(6) 2009; discharged (b)(6) 2009. Patient b: hospitalized on (b)(6) 2000; discharged (b)(6) 2009. Patient c: hospitalized on (b)(6) 2009; discharged (b)(6) 2009. Patient d: hospitalized on (b)(6) 2009; discharged (b)(6) 2009. Patient e: hospitalized on (b)(6) 2009; discharged (b)(6) 2009. Patient f: hospitalized on (b)(6) 2009; discharged (b)(6) 2009. Patient g: hospitalized on (b)(6) 2009; discharged (b)(6) 2009. Patient h: hospitalized on (b)(6) 2009; discharged (b)(6) 2009. Patient i: hospitalized on (b)(6) 2009; discharged (b)(6) 2009. On (b)(6) 2009, immediately upon discovery of the incorrect calibrations, the h machines were corrected, causing minor interruptions in treatment. After the machines were corrected, all the machines in the clinic were double checked by the chief technical officer. Both technical and clinical staff were re-educated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2009-00013 |
| MDR Report Key | 2627315 |
| Report Source | 05,06,07 |
| Date Received | 2009-05-18 |
| Date of Report | 2009-05-01 |
| Date of Event | 2009-03-03 |
| Date Facility Aware | 2009-03-02 |
| Report Date | 2009-04-20 |
| Date Reported to Mfgr | 2009-04-20 |
| Date Mfgr Received | 2009-05-04 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 2012-06-26 |
| 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 | 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS DIALYSIS MACHINE |
| Generic Name | 2008H |
| Product Code | FKP |
| Date Received | 2009-05-18 |
| Model Number | 2008H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS USA |
| Manufacturer Address | 2637 SHADELANDS DR WALNUT CREEK CA 94598 US 94598 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-18 |