Recall Z-1248-2019 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consis
| Date | Jun 21, 2018 |
| Status | Terminated |
| Reason | The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences. |
| Root cause | Process control |
| Action | On June 22, 2018, the firm notified customers by sending out an Urgent Medical Device Correction letter via USPS first class mail. Users were provided with affected serial numbers specific to their site, and informed that flow rate testing had not been properly executed on the identified devices. The firm is requesting the return of all affected devices to ensure proper testing is performed. ***Actions to be taken by Customers*** 1. Locate all affected pumps at your facility. 2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter Healthcare Med |
| Quantity | 158 |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, FA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, VT, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133801 | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY Baxter Healthcare Corporation, May 7, 2014 |