MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-02 for PRISMAFLEX * manufactured by Gambro Renal Products, Inc..
[16787836]
It appears that the patient received a large bolus of heparin. The machine history shows that the set was changed four times in twenty-two hours. On the fourth set change the machine did not respond to the end treatment instruction with a corresponding treatment complete response. Each of the other end treatment instructions, both on this patient and in our tests had a corresponding treatment complete response. The patient's partial thromboplastin time readings were 211 seconds after this event, and they were approximately 30 seconds twenty-four hours earlier. There is an indication that the patient actually got the extra heparin. The patient had no adverse response to the extra medication. The machine had many syringe pump alarms towards the end of treatment. In our tests we were unable to silence the syringe pump.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 710276 |
| MDR Report Key | 710276 |
| Date Received | 2006-05-02 |
| Date of Report | 2006-05-01 |
| Date of Event | 2006-04-25 |
| Report Date | 2006-05-01 |
| Date Reported to FDA | 2006-05-02 |
| Date Added to Maude | 2006-05-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX |
| Generic Name | CVVH |
| Product Code | KPF |
| Date Received | 2006-05-02 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 4 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 699324 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 10810 WEST COLLINS AVENUE LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-02 |