SapphireRecalls & reported problems across all models

We found 11 models of Sapphire by ICU Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2019 and Mar 7, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

8 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Sapphire recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 29, 2019Class IITerminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0147-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 29, 2019Class IITerminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0135-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jul 29, 2019Class IITerminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0134-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jul 29, 2019Class IITerminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0133-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Jul 29, 2019Class IITerminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0132-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Jul 29, 2019Class IITerminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0131-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Jul 29, 2019Class IITerminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0130-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Jul 29, 2019Class IITerminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0129-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Sapphire problems

Sapphire models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sapphire 1636202

  ACCESSORIES, PUMP, INFUSION
  1 recall3 reports
• Sapphire 1638401

  ACCESSORIES, PUMP, INFUSION
  1 recall1 report
• Sapphire 1633503

  ACCESSORIES, PUMP, INFUSION
  1 recall0 reports
• Sapphire 1636302

  ACCESSORIES, PUMP, INFUSION
  1 recall0 reports
• Sapphire 1637302

  ACCESSORIES, PUMP, INFUSION
  1 recall0 reports
• Sapphire 1638303

  ACCESSORIES, PUMP, INFUSION
  1 recall0 reports
• Sapphire 2401001

  ACCESSORIES, PUMP, INFUSION
  1 recall0 reports
• Sapphire 2401301

  ACCESSORIES, PUMP, INFUSION
  1 recall0 reports
• Sapphire 1638502

  ACCESSORIES, PUMP, INFUSION
  1 report
• Sapphire 1632402

  ACCESSORIES, PUMP, INFUSION
  1 report
• Sapphire 1637402

  ACCESSORIES, PUMP, INFUSION
  1 report

Recent Sapphire adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A NDEHP SAPPHIRE MIC NV +0.2FLTR. IT WAS REPORTED A LEAK OCCURRED FROM ONE OF THE SMALL PERFORATIONS ON THE IN-LINE FILTER. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM-AS PER THE ONCOLOGY PHARMACIST, THE MEDICATION ALSO LEAKED ONTO THE PATIENT'S T-SHIRT, NO SKIN IRRITATION WAS REPORTED. THE PATIENT WAS ADVISED TO THROW THAT T-SHIRT IN THE GARBAGE. THE TEAM WAS WEARING PPE FOR THIS INTERVENTION.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862904 ↗
• MalfunctionApr 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY SAPPHIRE¿ INFUSION SET, 1.2 MICRON FILTER, PAV, 123 INCH THAT DURING TESTING, AIR PASSED THROUGH THE FILTER AND DOWN THE LINE. THE CUSTOMER REPORTED THAT THE FILTER DID NOT CATCH THE AIR. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 10011706 ↗
• MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT NDEHP SAPPHIRE SET NV +1.2 FILTER WAS LEAKING. IT WAS FURTHER DESCRIBED BY THE CAREGIVER THAT TPN WAS LEAKING OF THE FILTER AND BLOOD HAD REFLUXED DOWN THE TUBING ALL THE WAY TO THE FILTER AND WAS ALSO LEAKING, RESULTING A PATIENT BEING SOAKED IN TPN AND BLOOD. THERE WERE ALSO SOME LARGE AIR SECTIONS VISIBLE CLOSER TO THE PATIENT THAN THE FILTER. THIS OCCURRED 1.5 HOURS AFTER THE IV PUMP WAS STARTED. THE PUMP SET ON 6PSI. THE PUMP DID NOT AUDIBLY ALARM. THE PATIENT HAD TO BE CLOSELY MONITORED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9227215 ↗
• MalfunctionOct 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A NDEHP SAPPHIRE MIC NV +.02FLTR THAT THE CUSTOMER REPORTED LEAKING AN UNKNOWN CHEMOTHERAPY MEDICATION FROM THE FILTER AREA. THERE WAS PATIENT INVOLVEMENT HOWEVER NO REPORT OF ADVERSE EVENT OF A DELAY IN THERAPY. THIS REPORT CAPTURES THE FIRST OF 2 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9184529 ↗
• MalfunctionOct 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A NDEHP SAPPHIRE MIC NV +.02FLTR THAT THE CUSTOMER REPORTED LEAKING AN UNKNOWN CHEMOTHERAPY MEDICATION FROM THE FILTER AREA. THERE WAS PATIENT INVOLVEMENT HOWEVER NO REPORT OF ADVERSE EVENT OF A DELAY IN THERAPY. THIS REPORT CAPTURES THE SECOND OF TWO DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9184511 ↗
• MalfunctionAug 27, 2019Crack; Crack

  THE EVENT INVOLVED A PATIENT THAT WAS RECEIVING BUPIVACAINE 0.2% + FENTANYL 2MCG/ML THROUGH AN EPIDURAL THAT WAS PLACED PRIOR TO TRANSFERRING TO PALLIATIVE CARE. IT WAS NOTED ON (B)(6) 2019, THAT THE EPIDURAL BAG THAT WAS STARTED ON (B)(6) 2019 HAD NOT SEEMED TO BE DISPENSING THE SOLUTION. THE PUMP LOOKED TO BE RUNNING THE ENTIRE TIME, AND THE PUMP NEVER ALARMED AT ANY TIME TO INDICATE THERE WAS A PROBLEM THAT IT WAS NOT DISPENSING THE SOLUTION. THE DRUG WAS INTENDED TO BE CONTINUOUSLY INFUSED THROUGHOUT THE TREATMENT. UPON REVIEW, THE SPIKE THAT ENTERED THE BAG LOOKED TO BE BROKEN. PICTURES PROVIDED BY THE CUSTOMER SHOW BROKEN PIECES OF THE SPIKE INSIDE THE CONNECTION PORT OF THE BAG. THE SITUATION RESULTED IN A PAIN CRISIS FOR THE PATIENT AND REQUIRED AN ANESTHESIA INTERVENTION THAT INCLUDED AN EPIDURAL ¿TOP-UP¿ TO ACHIEVE BETTER PAIN CONTROL. THERE WAS A DELAY IN THERAPY SINCE THE PATIENT DID NOT RECEIVE THE INTENDED TREATMENT UNTIL PUMP WAS REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8935301 ↗
• InjuryJan 8, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE EVENT INVOLVED A CUSTOMER ALLEGATION OF A PATIENT SCHEDULED TO RECEIVE DEXTROSE 10% WITH ELECTROLYTES AT 18MM, BUT WENT A LITTLE OVER 200MM VIA SAPPHIRE PRIMARY PIGGYBACK SET 2 CLAVE Y-SITE, 120 INCH ON (B)(6) 2018. DEXTROSE 10% WITH ELECTROLYTES WAS DISCONTINUED, A PEDIATRIC ENDOCRINOLOGIST WAS CONSULTED AND IV REGULAR INSULIN 0.15 UNITS/KG WAS GIVEN STAT TO TREAT A GLUCOSE OF 1834. THE PATIENT¿S GLUCOSE DECREASED TO 534 AND ANOTHER DOSE OF REGULAR INSULIN 0.15 UNITS/KG WAS GIVEN STAT. AFTER 30 MINUTES, THE GLUCOSE DECREASED TO 314. THE PATIENT WAS TRANSFERRED TO THE REGIONAL PEDIATRIC HOSPITAL FOR FURTHER ENDOCRINE ASSESSMENT. IT WAS MENTIONED THAT THE PRIMING METHOD USED WAS WITH THE PUMP AND APPROXIMATELY 20 ML OF VOLUME WAS USED FOR PRIMING. INITIALLY, THE VOLUME OF THE BAG WAS 515 ML AND APPROXIMATELY 375 ML WAS LEFT IN THE BAG WITH A VTBI DIFFERENCE OF 140 ML. THE PUMP WAS PLACED IN A CRADLE ACCESSORY DURING THE TREATMENT. IT WAS ALSO REPORTED THAT THE PUMP DID NOT ALARM AT THE BEGINNING, DURING, OR THE END OF THE TREATMENT. IT WAS ALSO REPORTED THAT THE PUMP NEVER ALARMED. THE NURSES CHECKED THE PUMP WITH 6 SECONDS LEFT WHEN PUMP WAS STOPPED. THE PUMP READ THAT 17.6 ML

  Patient problems: Hyperglycemia

  MAUDE report 8226471 ↗

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