MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-02-15 for OBS 10/02 SPS550 220V MSMCOMPATIBLE W/VARIABLE SODIUM FM4654 manufactured by Baxter Healthcare - Tampa.
[1317990]
Information was provided to the (b) (6) representative regarding hemodialysis patients positive for (b) (6) in hd center. The hemodialysis machines in use by the facility were sps550s. Reportedly, the local (b) (6) shut down the center for an investigation. Two sps550 units were used for the hd patients. Reportedly, the investigation requested information regarding the disinfection procedure for this device. The local national guidance on disinfection with chlorine bleach should be no less than 0. 5 hour. The baxter operator manual indicates use of the chlorine bleach for 15 minutes inside the dialysate flow tubing. Information was requested from baxter regarding the effectiveness of the disinfection procedure. Information has been received which suggests that the facility was reusing hemodialysis supplies. Additionally, information has been received which indicates that the facility does not follow the operator manual guidelines for disinfection of the device.
Patient Sequence No: 1, Text Type: D, B5
[1423448]
The patient presented with a major mi (b) (6) 2009/(b) (6) 2009 to another facility with no cardiac clinic. The patient was stabilized and transported one hour by ambulance to this facility. The patient was scheduled for a rotational atherectomy procedure, however, due to the facility not having a functioning rotablator console, the procedure was postponed 24 hours and the patient was hospitalized overnight. During the night, the patient began to experience episodes of hypertension and there was difficulty stabilizing the patient? S bp. The morning of the procedure, the patient began to have another mi. A temporary pacemaker was placed, however, it? Did not capture? And the patient was totally unresponsive with uncontrolled blood pressure. Three lesions in the rca were 80-90% stenosed and the diagonal was 70 stenosed. Due to the comorbidities, the patient was not a surgical candidate and due to severe calcification in the rca, the lesion could not be ballooned, rotational atherectomy was the only plausible treatment. The physician elected to continue with the procedure as medical management was not enough to ensure survival of the patient. The physician ablated with two burrs, placed three promus stents and post dilated with a maverick balloon. At the end of the procedure, images were taken and it was noted that the stents were well apposed, no evidence of dissection, thrombus or perforation. Timi iii flow was restored. The bp issue continued throughout the case, but did not worsen. As the physician was concluding the case, the patient had a right ventricular infarct. The patient was intubated and cpr commenced. The patient expired on the table. The cause of death was listed as right ventricle infarct complicated by pulmonary edema.
Patient Sequence No: 1, Text Type: D, B5
[8429773]
(b) (4). The device will not be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[8440802]
(b) (4). Additional information received clarified that the report applies to two baxter owned dialysis machines. Two baxter sps550 machines were identified. Report numbers (b) (4) and (b) (4) are opened to address the two baxter hemodialysis machines that were in use at this facility. This report was seen in media news on internet for the hospital. The media news stated that 10 plus patients were contaminated with (b) (6) in the hd center since mid of last year but the facility also had other brands of hemodialysis machines that were not produced by baxter in use at the facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2010-00129 |
| MDR Report Key | 1599106 |
| Report Source | 01,05 |
| Date Received | 2010-02-15 |
| Date of Report | 2010-01-18 |
| Date of Event | 2010-01-18 |
| Date Mfgr Received | 2010-02-23 |
| Date Added to Maude | 2010-03-04 |
| 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 | 0 |
| 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 - TAMPA |
| Manufacturer Street | 11210 MALCOLM MCKINLEY DRIVE |
| Manufacturer City | TAMPA FL 33612 |
| Manufacturer Postal Code | 33612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBS 10/02 SPS550 220V MSMCOMPATIBLE W/VARIABLE SODIUM |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2010-02-15 |
| Catalog Number | FM4654 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - TAMPA |
| Manufacturer Address | 11210 MALCOLM MCKINLEY DRIVE TAMPA FL 33612 33612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-15 |