Sapphire 1637402Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787007418), received between Aug 27, 2019 and Aug 27, 2019 — classified as 1 malfunction.

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

9 other recalls cover devices cleared under the same FDA submission (K171346); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171346. One submission often covers many models, so check the product and lot details in each record.

• Z-0134-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 1
• Z-0132-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, P
• Z-0131-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 11
• Z-0135-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore,
• Z-0133-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, C
• Z-0129-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit
• Z-0147-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore,
• Z-0130-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118
• Z-0619-2019 · Nov 8, 2018 · Terminated
  SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a conta