BAXTER
Received Aug 5, 2021 · Event occurred Aug 2, 2021
Report 12280163 · MDR key 12280163
Device
Product problems
- Product Quality Problem
- Infusion or Flow Problem
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
BAXTER HAS BEEN COMMUNICATING WITH YALE NEW HAVEN HEALTH TO PROPOSE SOLUTIONS TO OUR UNDER-INFUSIONS AND OCCLUSION ALARM PROBLEMS WITH THEIR SPECTRUM IQ IV PUMPS. THEY FEEL THIS IS ONE OF TWO SOLUTIONS. THE TRIPLE CARRIER, DESIGNED FOR CRITICAL CARE AREAS, WAS SENT TO OUR ORGANIZATION TO DEPLOY TO CLINICAL SITES, AT WHICH TIME CORPORATE SUPPLY CHAIN ASKED BAXTER REPRESENTATIVES, SALES, SENIOR LEADERSHIP, AND THE TEAM ADDRESSING OUR ISSUES TO CONFIRM TWO THINGS: THE BROCHURE HAS IT PICTURED WITH A TOTAL OF 6 PUMPS, BUT THERE ARE 12 OUTLETS WHICH MADE US SUSPECT THERE CAN BE A TOTAL OF 4 PUMPS PER POLE FOR A TOTAL OF 12 PUMPS ON THIS MODEL. THEY REPLIED TO THIS QUESTION ON DAY 12. IF THEY CAN CARRY 4 PUMPS PER POLE, WE WILL NOT BE ABLE TO MAINTAIN THE 22" HEAD HEIGHT FOR THE LOWEST PUMP AND IT WILL BE WELL OUTSIDE OF THE MANUFACTURER GUIDELINES. WE ASKED THEM TO SPECIFY HOW WE ARE TO ADDRESS THIS. AS OF BEGINNING OF AUGUST, THEY HAVE STILL NOT GIVEN GUIDANCE OR VISUAL AS TO HOW TO CORRECT FOR THIS. THEY REPLIED BY THE END OF JULY: "BAXTER DOES NOT MAKE RECOMMENDATIONS ON CARRIERS. WE PROVIDE THE ACCESSORY CATALOG AND SAMPLES FOR EVALUATION BY THE CLINICIANS. YOUR CLINICIANS WILL HAVE TO DETERMINE WHAT CARRIERS WORK BEST FOR THEIR CLINICAL PRACTICE WHICH COULD BE DIFFERENT FROM UNIT TO UNIT. BAXTER¿S ONLY REQUIREMENT IS THAT A HEAD HEIGHT OF 22¿ BE MAINTAINED TO ENSURE ACCURACY OF THE DEVICE. THE MODEL 2M0809 IV POLE CAN HOLD UP TO 12 PUMPS WHILE MAINTAIN THE 22¿ MINIMUM HEAD HEIGHT ON ALL PUMPS WHEN CONFIGURED CORRECTLY." OUR OBSERVATION: THE BAXTER MANUAL SAYS 24" +/- 2", SO IT ISN'T A ¿MINIMUM¿ HEAD HEIGHT. THAT IS WHERE THE CONFUSION LIES, SINCE THE PUMPS AT THE BOTTOM OF THE POLE WOULD BE WELL OUTSIDE THIS RANGE IF THE PUMP AT THE TOP IS WITHIN IT. I WILL ATTACH THE SNAPSHOT FROM THE MANUFACTURER GUIDELINES IN THIS REPORT. WE HAVE NOT DEPLOYED THE PUMPS TO CLINICAL SUITES AND ARE AWAITING CONFIRMATION.