Sapphire 1638502Recalls & reported problems
ICU Medical, Inc. · SAPPHIRE Primary Piggyback Set 2 CLAVE Y-Sites, 120 Inch · Class 2
All models of Sapphire (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787006503), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).
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
Device problems
- Excess Flow or Over-Infusion1
Patient problems
- Hyperglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Other ACCESSORIES, PUMP, INFUSION devices
- Medfusion 4000-0106-01Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls4,390 reports
- Medfusion 4000-0105-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls2,882 reports
- CADD 21-2111-0401-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION4 recalls461 reports
- CADD 21-2112-0402-78Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION3 recalls0 reports
- MEDFUSION 4000-0106-00Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls10 reports
- Medfusion 3500-0600-00Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls9 reports
- Medfusion 3500-0600-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls2 reports
- Medfusion 4000-0105-78Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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