ThermaCor 1200 Infusion System TIS-1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857893006004), received between Nov 19, 2018 and Dec 31, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K052055); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2020Device Alarm System; Disconnection; Insufficient Heating; Material Twisted/Bent

  PATIENT ADMITTED AS A TRAUMA FROM A FORKLIFT REQUIRING MASSIVE TRANSFUSION. HE WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY AFTER A POSITIVE FAST AND HYPOTENSION. HE REQUIRED A MASSIVE TRANSFUSION PROTOCOL IN THE OPERATING ROOM WHICH WAS ADMINISTERED THROUGH A THERMACOR RAPID TRANSFUSER. THE PLUG GOING INTO THE BACK OF THE THERMACOR WAS DISCONNECTED BECAUSE THE CLAMP KEEPING THE PLUG IN THE MACHINE WAS BENT. THE THERMACOR CONTINUED TO TRANSFUSE AT THE RAPID RATE SET BY THE ANESTHESIOLOGIST BUT DID NOT WARM THE BLOOD WHILE ON THE BATTERY BACKUP IN THE THERMACOR. THE PATIENT HAD A CARDIAC ARREST AND HAD A THORACOTOMY WITH OPEN HEART MASSAGE AND CARDIAC DEFIBRILLATION WITH RETURN OF A CARDIAC RHYTHM. HE HAD A SECOND CARDIAC ARREST THAT HE WAS NOT ABLE TO BE RESUSCITATED FROM. THE SURGEONS CONTINUED TO EXPLORE THE ABDOMEN. THE HEART STARTED SPONTANEOUSLY BEATING AFTER THE TRANSFUSIONS HAD STOPPED. THE ANESTHESIA TEAM NOTICED THAT THE THERMACOR WAS UNPLUGGED AND REPLUGGED IT INTO THE RAPID TRANSFUSER. THE PATIENT HAD A TOTAL OF 28 UNITS OF PRBC'S, 26 UNITS OF FFP, 4 UNITS OF PLTS AND 10 UNITS OF CRYOPRECIPITATE TRANSFUSED OVER THE COURSE OF THE CASE WHICH LAS

  Patient problems: Cardiac Arrest; Hypothermia

  MAUDE report 11107926 ↗
• MalfunctionOct 3, 2019Use of Device Problem; Use of Device Problem

  THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT (B)(6). THE UNIT EXHIBITED "HI TEMP" ERROR MESSAGE. THE UNIT WAS POWER CYCLED IN ORDER TO CLEAR THE ERROR MESSAGE; HOWEVER, THIS WAS UNSUCCESSFUL. THE HOSPITAL HAD TO SQUEEZE BAGS UNTIL THE SURGERY WAS COMPLETED. NO PATIENT INJURY WAS NOTED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9152714 ↗
• MalfunctionNov 19, 2018Crack; Display or Visual Feedback Problem; Connection Problem

  ALL ADULT CRITICAL CARE UNITS WERE TRANSITIONED TO THE THERMACOR FOR THE RAPID INFUSION OF FLUID AND BLOOD PRODUCTS IN 2016. PRIOR TO THIS CHANGE, ANOTHER LEVEL 1 RAPID INFUSER WAS USED. THIS CHANGE WAS ORIGINALLY PART OF AN INITIATIVE WITH LABOR AND DELIVERY, BUT THE SCOPE EXPANDED AS IT WAS DETERMINED THAT THE LEVEL 1 DEVICES WERE AGING AND WOULD BE INCOMPATIBLE WITH NEW IV FLUID BAGS BROUGHT IN DUE TO PRODUCT SHORTAGES. EACH ICU RECEIVED EXTENSIVE IN-SERVICING ON THE THERMACOR PRIOR TO IMPLEMENTATION. THIS EDUCATION HAS BEEN CONTINUED BY UNIT CLINICAL NURSE EDUCATORS TO MAINTAIN THE ONGOING COMPETENCY OF STAFF. DESPITE INITIAL AND ON-GOING EDUCATION EFFORTS, SEVERAL CHALLENGES USING THE THERMACOR? HAVE EMERGED: PATIENT SAFETY CONCERNS: USE OF THE THERMACOR? HAS RESULTED IN SIGNIFICANT DELAYS IN THE ADMINISTRATION OF BLOOD COMPONENTS DURING LIFE-THREATENING CLINICAL CONDITIONS REQUIRING MASSIVE AND RAPID TRANSFUSION. BLOOD AND BLOOD PRODUCTS ARE A PRECIOUS COMMODITY AND EACH TIME A THERMACOR? SET-UP FAILS, A SIGNIFICANT AMOUNT OF BLOOD IS WASTED. STAFF SAFETY CONCERNS: USERS HAVE BEEN EXPOSED TO BLOOD SPRAY FROM CRACKED AND EASILY DISCONNECTED TUBING. INEFFICIENT USE OF RESOURCES

  Patient problems: Exposure to Body Fluids

  MAUDE report 8083972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052055. One submission often covers many models, so check the product and lot details in each record.

• Z-1260-2021 · Feb 18, 2021 · Terminated
  ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood
• Z-1259-2021 · Feb 18, 2021 · Terminated
  ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood
• Z-1258-2021 · Feb 18, 2021 · Terminated
  ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood p