MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-03-15 for U1104 1550 SINGLE PATIENTSYSTEM 5M5538 manufactured by Baxter Healthcare - Largo.
[1337015]
The customer states that one patient generated an axsym toxo igg assay false negative result of less than 2. 0 iu/ml. The same patient came back to the lab about one month later and was redrawn and generated an axsym toxo igg assay result of positive (28 iu/ml). The customer then retested the original sample and generated a positive result of 26 iu/ml. No suspect results were reported from the lab and no impact to patient management was reported. A service call was initiated.
Patient Sequence No: 1, Text Type: D, B5
[8538349]
(b)(4). The device was evaluated in the clinic facility on (b)(6) 2010 by the field service technician. The alarm (b)(6) is related to a failure in the bypass valve or in the isolation valve. The evaluation of the technician confirmed the three way valve was not in good condition. The evaluation performed by the technician demonstrates the three way valve was filled with heavy metal due to the use of inadequate (unpure) water. The three way valve was cleaned and installed into the machine. The device was considered ready for use.
Patient Sequence No: 1, Text Type: N, H10
[15696656]
On (b) (6) 2010 a report was received from a facility nurse stating that the 1550 single patient system machine had ultrafiltration during patient hemodialysis therapy resulting in the patient experiencing hypotension and diaphoresis. The device was programmed to filtrate 3. 3 but the machine actually filtrated 4. 4. The nurse stated the device showed a failure code "fl06". 1000ml saline solution intravenous (iv) was administered to the patient. The patient was observed for 40 minutes and the patient improved. The physician was notified of the event. The nurse followed up with the patient later that day and he felt good. This is a male patient, (b) (6). The failure code (fl06) that occurred on the hemodialysis machine involved indicates a failure in the three-way bypass/isolation valve. Reportedly, the device had preventive maintenance on (b) (6) 2010 prior to the event and on (b) (6) 2010, after the event. The technician evaluated the device at the facility. Results of evaluation indicates therapy was performed on this machine using acueduct water (this means untreated water). The technician also indicated that the water used in this baxter renal clinic is proper (treated) water, but the machine is also used in other clinics where untreated water is used. The acueduct (untreated) water results in the three-way valve having a build-up of heavy metal residue.
Patient Sequence No: 1, Text Type: D, B5
[15889978]
(b) (4). The field service technician went to the clinic and evaluated the device. Currently, the date of the evaluation is unknown and the final results of the evaluation have not yet been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2010-00224 |
| MDR Report Key | 1630223 |
| Report Source | 01,05 |
| Date Received | 2010-03-15 |
| Date of Report | 2010-02-24 |
| Date of Event | 2010-02-23 |
| Date Mfgr Received | 2010-03-19 |
| Date Added to Maude | 2010-03-29 |
| 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 | 0 |
| Manufacturer Contact | KAREN KIRBY |
| 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 - LARGO |
| Manufacturer Street | 7511 114TH AVE. NORTH |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | U1104 1550 SINGLE PATIENTSYSTEM |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2010-03-15 |
| Catalog Number | 5M5538 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - LARGO |
| Manufacturer Address | 7511 114TH AVE. NORTH LARGO FL 33773 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-15 |