HMS PLUS 30514 (UDI 00673978698793)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00673978698793), received between Feb 17, 2022 and Sep 22, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (63 reports).

1 other recall cover devices cleared under the same FDA submission (K894317); they may or may not involve this specific model.

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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Electrical /Electronic Property Problem

  Medtronic received information that prior to use of a HMS plus instrument, it was reported that the system was displaying a dispensing terminated message and failing HPT QC. The instrument was used. There was no patient involvement, so no adverse effect occurred. Medtronic received additional information that HPT was a liquid control that customer was running. When customer was using instrument to run daily liquid controls (during HPT control test), some type of stall occurred, stopping the test from its completion. So, the test Failed. Quality control is performed for this unit weekly. There wasn't an error code associated with this issue observed. Control values were not obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852835 ↗
• MalfunctionOct 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT FAILS QUALITY CONTROL TEST, AND IS UNABLE TO PRINT QC TEST RESULTS. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369741 ↗
• MalfunctionSep 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE (DURING TESTING) OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE LEVELS WERE NOT READING CORRECTLY. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEVELS ARE RELATED TO LIQUID CONTROLS. NO ERROR CODES WERE ASSOCIATED WITH THE REPORTED ISSUE. NO CONTROL VALUES WERE OBTAINED AND THE LOT NUMBER FOR USED CARTRIDGES ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937486 ↗
• MalfunctionJun 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT WAS FAILING QUALITY CONTROL. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. SERVICE SPOKE TO THE CUSTOMER OVER THE PHONE AND NO ERRORS WERE ALARMING. CUSTOMER WAS ADVISED TO CLEAN THE HEATING BLOCK AND TRY A DIFFERENT LOT NUMBER OF CARTRIDGES AND CONTROLS. THIS IS NOT A MECHANICAL ISSUE. REFERRED CUSTOMER TO BEN SMITH. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329017 ↗
• MalfunctionJun 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THIS UNIT WAS FAILING ABNORMAL CONTROLS INTERMITTENTLY. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE IS BETTER DUE TO RETRAINING STAFF ON QC TECHNIQUE, BUT THE ACCOUNT STILL ENCOUNTERS RANDOM FAILURES WITH THIS INSTRUMENT. THEIR DIFFERENT HMS INSTRUMENTS PASS ALL OTHER QC TESTING. THE CUSTOMER IS WATCHING THE QC RESULTS WEEKLY AND WILL ADVISE THE CLINICAL SPECIALIST IF THE FAILURES INCREASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317921 ↗
• MalfunctionJun 20, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT WAS NOT PASSING QUALITY CON TROL, AND WHEN THEY DO PASS THE MEASUREMENTS ARE OUT OF RANGE AND TOO LOW. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296494 ↗
• MalfunctionJun 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE HMS PLUS INSTRUMENTS IT WAS NOTED THAT THE INSTRUMENTS WERE FAILING FLAG HEIGHT AND RECEIVING ABNORMAL QUALITY CONTROL RESULTS. THE SAME RESULTS WERE OBSERVED WHEN USING THREE DIFFERENT CARTRIDGES AND INSTRUMENTS. THE INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182669 ↗
• MalfunctionJun 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE HMS PLUS INSTRUMENTS IT WAS NOTED THAT THE INSTRUMENTS WERE FAILING FLAG HEIGHT AND RECEIVING ABNORMAL QUALITY CONTROL RESULTS. THE SAME RESULTS WERE OBSERVED WHEN USING THREE DIFFERENT CARTRIDGES AND INSTRUMENTS. THE INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182647 ↗
• MalfunctionMay 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT IT INTERMITTENTLY FAILED ABNORMAL CO NTROLS. THE INSTRUMENT WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103413 ↗
• MalfunctionMay 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THERE WERE ABNORMAL QUALITY CONTROL FAILURES. THE DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SERVICE SENT CUSTOMER ABNORMAL CONTROLS TO RUN ON DEVICE. DEVICE CONTINUED TO INTERMITTENTLY FAIL WHEN RUNNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103387 ↗
• MalfunctionMay 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE HMS PLUS DEVICE WAS UNABLE TO PASS THE LIQUID QUALITY CONTROL. THE SITE ATTEMPTED USING TWO DIFFERENT LOTS, BUT THERE WAS NO CHANGE IN THE OUTCOME. A BACKUP DEVICE WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094863 ↗
• MalfunctionMay 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE HMS PLUS INSTRUMENT DEVICE WAS FAILING LIQUID QUALITY CONTROL. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT QUALITY CONTROL IS PERFORMED WEEKLY FOR THIS UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22086654 ↗
• MalfunctionMay 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT HAD AN INTERMITTENT ABNORMAL QUALITY CONTROL FAILURE. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060556 ↗
• MalfunctionMay 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT DURING A QUALITY CONTROL (QC) HIGH R ANGE ACTIVATED CLOTTING TIME (HR-ACT) TEST, THE FIRST TIME, IT WOULD PASS, BUT THE SECOND TIME WOULD ALWAYS FAIL. THE CUSTOMER REBOOTED THE SYSTEM THREE TIMES AND REPORTED THAT IT FAILED ALL THREE TIMES. THE AVERAGE ACT WAS 297 SECS AND THE LAST FAIL WAS 300 AND 294 SECS. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION CONFIRMING THAT THE ISSUE WAS SPECIFICALLY RELATED TO THE ABNORMAL LIQUID CONTROL FAILING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059640 ↗
• MalfunctionMay 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE SYSTEM WAS GIVING AN ABNORMAL CO NTROL THAT IS OUTSIDE THE MAXIMUM RANGE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC SERVICE SPOKE TO BIOMED, AND RECOMMENDED RERUN LIQUID QC BUT TO RECONSTITUTE CONTROLS FOR AT LEAST 30MIN BEFORE CONTROLS ARE RUN. BIOMED WAS ABLE TO PASS ABNORMAL QC WITHOUT ERROR. NO SERVICE IS NEEDED OR REQUIRED. NO FURTHER ACTION REQUIRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044069 ↗
• MalfunctionMay 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE HIGH RANGE ABNORMAL ACT LIQUID CONTROLS WERE INCREASINGLY DIFFICULT TO PASS TESTING. RESULTS REPORTED WERE NOT IN RANGE, TEST FAILED. THE CUSTOMER RAN THE HIGH RANGE CLOT TRACT ABNORMAL CONTROL. THEY RAN MULTIPLE TIMES AND STILL FAILED. THE ACT NORMAL LIQUID CONTROL PASSED, CLOT TRACT HR NORMAL CONTROLS PASSED ON OTHER HMS SYSTEMS AT THE FACILITY. ALL OTHER LIQUID CONTROLS PASSED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBERS OF CONTROL CARTRIDGES USED WAS 230668178 AND 231056297. QUALITY CONTROL IS PERFORMED FOR THIS UNIT EVERY 7 DAYS. THERE WAS NO ERROR CODE.CONTROL VALUES WERE NOT OBTAINED.CHANNEL 5 : 298,CHANNEL 6 : 305.ALL OTHER CONTROLS PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042618 ↗
• MalfunctionMay 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT HAD FAILED THE ACT ABNORMAL CONTROL MULTIPLE TIMES OVER THE PAST MONTH. AN ANESTHESIA TECHNICIAN REPEATED THE TEST USING THE SAME SAMPLE, WHICH AGAIN RESULTED IN FAILURE. THE TEST WAS REPEATED USING TWO NEW SAMPLES AND BOTH ALSO FAILED. THE ORIGINAL SAMPLE INITIALLY FAILED WAS USED TO PERFORM QUALITY CONTROL (QC) ON THE OTHER TWO INSTRUMENTS AND PASSED. THE CARTRIDGES AND QC MATERIALS WERE CHECKED AND FOUND TO BE WITHIN EXPIRATION DATES. THE TEMPERATURE WAS RECORDED WITHIN THE ACCEPTABLE RANGE. ALL OTHER CONTROLS PASSED ON THIS INSTRUMENT, AND NO QC ISSUES WERE OBSERVED ON THE OTHER TWO USED INSTRUMENTS. A DIFFERENT ANESTHESIA TECHNICIAN ATTEMPTED THE TEST AGAIN THE FOLLOWING DAY USING A SAMPLE FROM A DIFFERENT BOX, BUT THE TEST STILL FAILED. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980325 ↗
• MalfunctionMay 1, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE CUSTOMER WAS GETTING INCONSISTENT QC RESULTS. CUSTOMER WAS TRYING TO SET THEIR OWN QC RANGE THAT THEY FIND ACCEPTABLE BUT WHEN RUNNING MULTIPLE TESTS BY MULTIPLE PERFUSIONISTS THEY WERE GETTING VARYING RESULTS. SOME OF WHICH FELL OUT SITE OF WHAT IS LISTED IN THE MANUAL. CUSTOMER WAS USING DIFFERENT CARTRIDGES AND LOTS. UNKNOWN LOT NUMBERS AT TIME OF CALL. NO OTHER INFORMATION AVAILABLE AT TIME OF CALL. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942013 ↗
• MalfunctionMay 1, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE QUALITY CONTROL, THIS HMS PLUS INSTRUMENT HAD PROBLEMS WHILE DOING QUALITY CONTROLS ONLY WITH WHITE AND GOLD CARTRIDGES. TWO DIFFERENT CARTRIDGES WERE TESTED AND THEY DID NOT PASS. TESTS PERFORMED WITH ORANGE AND RED CARTRIDGES WERE AS EXPECTED AND THE ACTIVATED CLOTTING TIME (ACT) TEST ALSO PASSED. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT LIQUID CONTROLS WERE USED FOR THE WHITE CARTRIDGES. THE CARTRIDGE LOT #: 230693744, CONTROL LOT #: 226864816 AND CARTRIDGE LOT #230463115, CONTROL LOT # 228511174 WERE USED. QUALITY CONTROL IS PERFORMED ONCE A WEEK FOR THIS INSTRUMENT. THERE WERE THREE TESTS TRIED, CONTROL LOT NUMBER AND CARTRIDGE WERE CHANGED, AND NEITHER WORKED. CARTRIDGES WERE SENT BACK FOR TESTING, AND NO MORE WHITE CARTRIDGES WERE USED ON THAT MACHINE. CONTROL VALUES WERE NOT OBTAINED. THE CUSTOMER CAN NOT USE THE MACHINE ON PATIENT REQUIRING THE WHITE CARTRIDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941022 ↗
• MalfunctionApr 20, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT WAS UNABLE TO PASS THE LIQUID QUALITY CONTROL. THE CUSTOMER TRIED MULTIPLE LOTS AND REBOOTING THE SYSTEM WITH NO CHANGE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870315 ↗
• MalfunctionApr 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT HAD FAILED THE ACT ABNORMAL CONTROL(QC) MULTIPLE TIMES OVER THE PAST MONTH. AN ANESTHESIA TECHNICIAN REPEATED THE TEST USING THE SAME SAMPLE, WHICH AGAIN RESULTED IN FAILURE. THE TEST WAS REPEATED USING TWO NEW SAMPLES AND BOTH ALSO FAILED. THE ORIGINAL SAMPLE INITIALLY FAILED WAS USED TO PERFORM QUALITY CONTROL (QC) ON THE OTHER TWO INSTRUMENTS AND PASSED. THE CARTRIDGES AND QC MATERIALS WERE CHECKED AND FOUND TO BE WITHIN EXPIRATION DATES. THE TEMPERATURE WAS RECORDED WITHIN THE ACCEPTABLE RANGE. ALL OTHER CONTROLS PASSED ON THIS INSTRUMENT, AND NO QC ISSUES WERE OBSERVED ON THE OTHER TWO USED INSTRUMENTS. A DIFFERENT ANESTHESIA TECHNICIAN ATTEMPTED THE TEST AGAIN THE FOLLOWING DAY USING A SAMPLE FROM A DIFFERENT BOX, BUT THE TEST STILL FAILED. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863402 ↗
• MalfunctionMar 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE THIS HMS PLUS INSTRUMENT, THERE WAS INCREASED DIFFICULTY IN GETTING LIQUID ACT ABNORMALS TO PASS TESTS, AND CLOT DETECTION OCCURRED SLIGHTLY EARLY OF THE PRESCRIBED RANGE. ALL OTHER LIQUID CONTROLS PASSED WITHIN THE ACCEPTABLE RANGES. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616612 ↗
• MalfunctionMar 14, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT AT AN UNSPECIFIED TIME THIS HMS PLUS INSTRUMENT HAD AN ABNORMAL QC FAILURE. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DECLINED SERVICE STATING THAT THE INSTRUMENT WAS WORKING FINE. NO FURTHER ACTION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603659 ↗
• MalfunctionMar 13, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, THERE WAS INCREASED DIFFICULTY IN GETTING LIQUID ACT ABNORMALS TO PASS TESTS, AND CLOT DETECTION OCCURRED SLIGHTLY EARLY OF THE PRESCRIBED RANGE. ALL OTHER LIQUID CONTROLS PASSED WITHIN THE ACCEPTABLE RANGES. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596458 ↗
• MalfunctionMar 13, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, THERE WAS INCREASED DIFFICULTY IN GETTING LIQUID ACT ABNORMALS TO PASS TESTS, AND CLOT DETECTION OCCURRED SLIGHTLY EARLY OF THE PRESCRIBED RANGE. ALL OTHER LIQUID CONTROLS PASSED WITHIN THE ACCEPTABLE RANGES. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596410 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K894317. One submission often covers many models, so check the product and lot details in each record.

• Z-1070-2010 · Dec 14, 2009 · Terminated
  Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting bloo