Regulated Software Application (RSA) 1.0.19.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00860664000309), received between Nov 15, 2016 and Dec 24, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2019Nonstandard Device; Nonstandard Device

  ON 12/04/2019, ONEBLOOD BECAME AWARE THAT UNDER RARE CIRCUMSTANCES, RSA APPLIES AN INCORRECT EXPIRATION DATE TO LIQUID POOLED PLASMA PRODUCTS. THIS ANOMALY ONLY APPLIES THE INCORRECT 1-YEAR EXPIRATION DATE TO LIQUID POOLED PLASMA PRODUCTS IF THE PRODUCT WAS ORIGINALLY MANUFACTURED AS AN 8 OR 24-HOUR FROZEN POOLED PLASMA PRODUCT, WHICH IS THEN EDITED TO A LIQUID POOLED PLASMA PRODUCT. UNDER THIS RARE SITUATION, THE SYSTEM WOULD DETERMINE THE EXPIRATION DATE BASED ON THE INDIVIDUAL POOLED PLASMA PRODUCT EXPIRATION DATE INSTEAD OF THE FINAL POOLED PLASMA PRODUCT EXPIRATION DATE. HOWEVER, WHEN A LIQUID POOLED PLASMA PRODUCT IS ORIGINALLY MANUFACTURED AND LABELED WITHOUT EDITING THE CORRECT 26 DAY EXPIRATION DATE IS APPLIED AND PRINTED ON THE PRODUCT LABEL. 1 UNIT WAS FOUND TO BE AFFECTED AND LABELED WITH THE INCORRECT EXPIRATION DATE; AS A RESULT, 3 PRODUCT BAGS WERE SHIPPED BUT SUCCESSFULLY RETURNED. NO UNSUITABLE PRODUCTS WERE TRANSFUSED TO PATIENTS. ON 12/05/2019, A SOFTWARE DATABASE CHANGE WAS PERFORMED TO DEACTIVATE THE EDITING OF ALL POOLED PLASMA PRODUCTS TO PREVENT THIS SCENARIO FROM REOCCURRING. ADDITIONALLY, THE USER GROUP WAS ADVISED OF THE ISSUE AND THE DISABLEMENT OF THE E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517030 ↗
• MalfunctionDec 18, 2019Nonstandard Device; Nonstandard Device

  DESCRIBE EVENT: ON (B)(6) 2019, ONEBLOOD BECAME AWARE THAT UNDER RARE ATYPICAL NONCOMPLIANT USER CIRCUMSTANCES, RSA WILL NOT PREVENT A USER FROM FURTHER MANUFACTURING A WHOLE BLOOD PARENT PRODUCT AFTER THE PARENT PRODUCT WAS DISCARDED. THIS OCCURS WHEN THE USER INCORRECTLY SELECTS THE WRONG PRODUCT (WB PARENT) IN STERILE CONNECTION, AND THEN DISCARDS THE WB PARENT AT THE COMPLETION OF THE STERILE CONNECTION PROCESS INSTEAD OF THE UNSUITABLE CHILD PRODUCT. SIMILARLY, THE SOFTWARE IS NOT PREVENTING THE USERS FROM CARRY OUT A STERILE CONNECTION PROCESS ON A PRODUCT SUCH AS WHOLE BLOOD, WHILE THE PRODUCT WAS ALREADY MANUFACTURED FURTHER INTO INDIVIDUAL COMPONENTS. THEREFORE, IN THESE RARE SITUATIONS, THE SYSTEM IS NOT PREVENTING THE UNSUITABLE CHILD PRODUCT FROM BEING LABELED AND SHIPPED. 2 PRODUCTS WERE LABELED AND SHIPPED BUT WERE SUCCESSFULLY EITHER RECALLED OR DISCARDED AT THE HOSPITAL. 11 TOTAL PRODUCTS HAVE BEEN IDENTIFIED AS AFFECTED UNDER THIS SCENARIO. 5 OF THESE PRODUCTS WERE DISCARDED IN HOUSE AND NEVER SHIPPED. 4 ADDITIONAL PRODUCTS WERE SHIPPED BUT INVESTIGATION INTO THEM DETERMINED THE SHIPPED PRODUCT TO BE SUITABLE AND ONLY REPRESENT AN ERROR IN DOCUMENTATION. MDR IS BEI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9488908 ↗
• MalfunctionDec 18, 2019Nonstandard Device; Nonstandard Device

  ON (B)(6) 2019, ONEBLOOD BECAME AWARE THAT UNDER RARE ATYPICAL NONCOMPLIANT CIRCUMSTANCES, RSA WILL NOT PREVENT A USER FROM COLLECTING BLOOD FROM A DONOR WITH A HEMOGLOBIN (HGB) BELOW THE LOWER ACCEPTABLE LIMIT. THE SOFTWARE ANOMALY IN QUESTION TAKES PLACE DURING THE PROCESS OF ENTERING A DONOR'S "PHYSICAL EXAM" INFORMATION, WHICH INCLUDES DATA SUCH AS BLOOD PRESSURE, PULSE, TEMPERATURE, WEIGHT, HEIGHT, AND HGB. RSA PROVIDES A WAY FOR USERS TO ENTER A SECOND HGB VALUE IF THE FIRST VALUE PROVIDED WAS TOO LOW TO MEET DONATION ELIGIBILITY REQUIREMENTS (AS DETERMINED BY SOFTWARE VALIDATION), AND THE USER DETERMINES THAT A REPEAT TEST IS APPROPRIATE BASED ON BLOOD CENTER SOP. IN RARE SITUATIONS, THE SYSTEM VALIDATION IS NOT APPLYING A DONOR DEFERRAL AUTOMATICALLY, WHICH WOULD PREVENT INELIGIBLE COLLECTION WHEN A SECOND, LOW, HGB VALUE IS ENTERED AND A DONOR HEIGHT VALUE IS NOT. 0 UNITS WERE COLLECTED FROM DONORS WHO HAD HGB LEVELS TOO LOW TO MEET ELIGIBILITY CRITERIA. HOWEVER, 68 DONOR RECORDS WERE IDENTIFIED AS HAVING NO AUTOMATIC DEFERRALS PLACED ON THEM DUE TO THE ABOVE SCENARIO; EACH OF THE 68 WERE DISCOVERED BY STAFF AT THE PROPER TIME AND THE DONATION PROCESSES CEASED. THE DONOR I

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9488760 ↗
• MalfunctionNov 15, 2016Incorrect Software Programming Calculations; Incorrect Software Programming Calculations

  ON 10/21/2016, ONEBLOOD, INC. IDENTIFIED THAT SPECIFIC USER CIRCUMSTANCES COULD ALLOW A POTENTIALLY INELIGIBLE DONOR TO BE ACCEPTED DESPITE ANSWERING "NO" TO DONOR HISTORY QUESTIONNAIRE (DHQ) QUESTION #1: "ARE YOU FEELING HEALTHY AND WELL TODAY". WHEN A DONOR ANSWERS AN ELECTRONIC DHQ ADMINISTERED VIA A TABLET COMPUTER, THE DHQ IS SUBMITTED FOR REVIEW AND FOLLOW UP WITH THE POTENTIAL DONOR BY A ONEBLOOD HEALTH HISTORY SCREENER. AFTER REVIEW WITH THE DONOR, THE DHQ IS SUBMITTED, THE STAFF MEMBER WILL INVESTIGATE THE ANSWER AND NOT ALLOW THE DONOR TO DONATE AND THE SYSTEM APPLIES ANY APPLICABLE DEFERRALS BASED ON DHQ ANSWERS. FOR DHQS COMPLETED VIA A TABLET, TESTING HAS CONFIRMED THAT THE INTENDED ONE-DAY DEFERRAL THAT SHOULD BE PLACED ON THE DONOR IS NOT BEING APPLIED RESULTING IN A POTENTIALLY INELIGIBLE DONOR TO BE ACCEPTED DESPITE ANSWERING THE DHQ IN A DEFERRABLE WAY. THIS FAILURE SCENARIO HAS BEEN CONFIRMED TO ONLY OCCUR IF THE DHQ RESPONSE TO QUESTION #1 IS ANSWERED BY THE DONOR USING A TABLET. ALL OTHER METHODS OF DHQ COMPLETION HAVE BEEN CONFIRMED TO NOT REPRESENT THIS RISK. ADDITIONALLY, THE FAILURE WOULD ONLY MANIFEST IF STAFF INCORRECTLY ALLOW PROGRESSION OF THE DONATION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104457 ↗