Recall Z-0528-2008 ยท KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Baxter Healthcare Renal Div
Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085.
| Date | Jan 26, 2008 (initiated Nov 14, 2007) |
| Status | Terminated |
| Reason | Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only). |
| Root cause | Software design |
| Action | Baxter Healthcare Corporation sent an Urgent Device Correction letter, dated 11/14/07, to all of the affected customers, informing them of the Heparin Bolus and the Withheld Medication issues and provided them with interim mitigation instructions that they should implement while waiting for a software correction. A Baxter representative will contact the customer to schedule the software update when the upgraded software is released. Customers were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff, and indic |
| Quantity | 9 units |
| Distribution | Worldwide Distribution-USA including Puerto Rico, and countries of Australia, Austria, Canada, Chile, Denmark, Finland, Greece, Ireland, Italy, Mexico, The Netherlands, New Zealand, Norway, Panama, Portugal, Spain, Sweden and the United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061515 | RENALSOFT Baxter Healthcare Corp, Sep 11, 2006 |