MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-05-02 for FREEDOM CYCLER PD+ PD+IQCARD NA manufactured by Fresenius Medical Care North America.
[18473870]
A patient reportedly was overfilled during a ccpd treatment. The ccpd fill volume is 1,000 ml. The nurse saw the volume gradually increase to 0-200 and left the room. When she came back, the cycler was giving a scale alarm and the drain bags were swinging. She stabilized the bags, cleared the alarm and resumed treatment. She did not check the fill volume at this time. She left the patient for about 20 minutes and when she came back, patient was short of breath and very uncomfortable. Two of the four solution bags were almost empty. She did not check the fill volume and bypassed to drain 1. The patient drained 4,000 ml. The cycler gave a therm. Alarm so she disconnected the patient. She connected the patient to another cycler and resumed the drain. Patient drained an additional 1870 ml. There was no serious injury/illness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2003-00012 |
| MDR Report Key | 458273 |
| Report Source | 05 |
| Date Received | 2003-05-02 |
| Date of Report | 2003-04-04 |
| Date of Event | 2003-04-04 |
| Date Facility Aware | 2003-04-04 |
| Report Date | 2003-04-04 |
| Date Mfgr Received | 2003-04-04 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2003-05-09 |
| 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 | 0 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM CYCLER PD+ |
| Generic Name | PERITONEAL DIALYSIS CYCLER |
| Product Code | KPF |
| Date Received | 2003-05-02 |
| Model Number | PD+IQCARD |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 447235 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | 2637 SHADELANDS DR. WALNUT CREEK CA 94598 US |
| Baseline Brand Name | FREEDOM CYCLER PD+ |
| Baseline Generic Name | PERITONEAL DIALYSIS CYCLER |
| Baseline Model No | PD+IQCARD |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-05-02 |