MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2008-05-06 for HOMECHOICE CYCLER-REFURBISHED 5C4471R manufactured by Baxter Healthcare.
[843276]
The nurse (rn) of a home pt (hp) contacted a technical svc rep (tsr) in 2008 and reported the hp was fluid overloaded using the homechoice sys. The incident was reviewed over the phone with the tsr, which revealed the pt was hospitalized. The rn requested a swap and the tsr subsequently swapped the hp's device. Follow up with the rn on nine days later revealed the hp was hospitalized for one week due to fluid overload and was released from the hosp on original date, at which time the rn swapped the cycler. The hp had pancreatitis while hospitalized, which the rn feels may have been caused by the hp being fluid overloaded. The rn does not feel that any device failure or malfunction had occurred. The rn felt that the hp's hospitalization was caused by the hp being underdialyzed as a result of her own user error. The hp kept repeatedly changing the prescription on her cycler, and the rn had to make 3 separate home visits to correct it. The rn relates that on one occasion she found that the total volume of fluid to be used for the automated peritoneal dialysis (apd) therapy had been changed on the cycler by the hp from 12000mls to 2000mls. The rn relates that the hp seemed to have lost faith in the cycler, and she swapped it out in the hopes that this would stop the hp from changing the cycler's programming. The rn indicates that the hp was dialyzed at the hosp, using the hospital's cycler and she has no specific details regarding the hp's weight or treatment received. The rn relates that the hp has been using the replacement cycler and has already attempted to alter the programming on it. The rn has been working with the hp's social worker to try and resolve these issues. Corporate prod surveillance informed the rn of the program locked feature of the cycler, which is accessible to the rn only from the nurse's menu. Rn relates that as a result of this and the cross-reference complaint incident, she will lock the hp out of the programming in order to prevent her from making changes to it in the future.
Patient Sequence No: 1, Text Type: D, B5
[8029211]
The device has been requested to go to the prod analysis lab for eval. A follow up report will be filed upon completion of the eval or if add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00316 |
| MDR Report Key | 1038512 |
| Report Source | 00,05 |
| Date Received | 2008-05-06 |
| Date of Report | 2008-04-09 |
| Date of Event | 2008-04-01 |
| Date Mfgr Received | 2008-04-09 |
| Date Added to Maude | 2008-05-15 |
| 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 | 0 |
| 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 | 04/09/2008 |
| 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 | 2008-05-06 |
| Returned To Mfg | 2008-04-15 |
| Catalog Number | 5C4471R |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1009483 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-05-06 |