MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-05-14 for HOMECHOICE CYCLER-REFURBISHED 5C4471R manufactured by Baxter Healthcare.
[19553508]
The registered nurse (rn) contacted baxter's technical svc ctr regarding the home pt (hp) not being able to do dialysis for the last two days due to alarms. The tsr reviewed the alarm log several sys error 2001 alarms, a reload set 160 alarm and a reload set 177 alarm. The hp kept ending the therapy and attempted several times to do therapy by setting up with new supplies. The rn said that the hp was severely overfilled because she had not done the therapy correctly for the past two days. For the past two days, the hp has been getting several alarms. The hp has made several attempts to do therapy by setting up with new supplies. The rn will program. Baxter's technical svc ctr arranged a swap of the instrument due to this issue.
Patient Sequence No: 1, Text Type: D, B5
[19713606]
Four simulated pt therapies were attempted using the pt's therapy settings. Three were aborted due to sys error (se) 2201 and one was aborted due to a se 2088. The software was then used to monitor the devices pneumatic sys. No problems were revealed and all pressures were correct and stable. The device passed the seal & purge test and the wet disposable test. The cover was opened and an overall general internal inspection performed on the device. All connections appeared correct and secure. The inspection did reveal fluid within the volumetric standard right (vsr) cup and the vsr tubing. Because fluid was present in the pneumatic sys the device repeatedly alarmed and accuracy testing could not be performed. The fluid in the pneumatic sys caused the device to fail in a safe mode by alarming 2201 and 2088 as the pal encountered as well as the 160 and 177 recorded in the alarm log. Any fluid within the pneumatic sys can cause numerous errors. The reported difficulty of se 2001 (left volume initial calculation(, rls 160 (left disposable volumetric final maximum failed) and rls 177 (post and rd do not compare) were all confirmed in the alarm log. The reported difficulty of severe overfill was not confirmed in the logs or duplicated during testing. The event log was down loaded and therapy and alarm logs were obtained. Simulated pt therapies were attempted. The device svc record was reviewed. Internal and external visual inspections were performed. Fluid was found within the pneumatic sys. The reported difficulty of severe overfill was not confirmed in the logs or duplicated during testing. An internal inspection revealed fluid within the volumetric standard right errors, including the ones encountered in the prod analysis lab (pal) as well as the recorded se's contained in the logs. Due to the fluid within the pneumatic sys, further testing was not able to be performed. The device will be scrapped.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00355 |
| MDR Report Key | 1045711 |
| Report Source | 04 |
| Date Received | 2008-05-14 |
| Date of Report | 2007-05-14 |
| Date of Event | 2007-05-13 |
| Date Mfgr Received | 2007-10-30 |
| Date Added to Maude | 2008-05-22 |
| 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 | 0 |
| Manufacturer Contact | KAREN KIRBY, COMPL MGR |
| Manufacturer Street | 25212 W ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE |
| Manufacturer Street | DOCK 10 |
| Manufacturer City | LARGO FL 33777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOMECHOICE CYCLER-REFURBISHED |
| Generic Name | 78FKK |
| Product Code | FKK |
| Date Received | 2008-05-14 |
| Returned To Mfg | 2007-05-18 |
| Catalog Number | 5C4471R |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1015918 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2008-05-14 |