CADD 21-7095-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586025273), received between Aug 28, 2019 and Oct 15, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K933390); 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.

• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WITH AIR-ELIMINATING FILTER WAS LEAKING AT THE FILTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194991 ↗
• MalfunctionAug 29, 2019Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED. THE KIT WAS USE TO ADMINISTER 133.8 UG POUCH OF BLINCYTO WITH THE SOLIS VIP 2120 CADD PUMP FOR A 96-HOUR HOME DELIVERY. AFTER MORE OR LESS THAN 42 HOURS OF THE CONNECTION, THE PATIENT NOTICED THAT THERE WAS A LEAK IN THE 0.22 UM FILTER. THE INFUSION HAD TO BE PREPARED AGAIN DUE TO THE AMOUNT OF MEDICATION THAT WAS LEAKED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 8946518 ↗
• MalfunctionAug 28, 2019Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED. THE KIT WAS USE TO ADMINISTER 133.8 UG POUCH OF BLINCYTO WITH THE SOLIS VIP 2120 CADD PUMP FOR A 96-HOUR HOME DELIVERY. AFTER MORE OR LESS THAN 42 HOURS OF THE CONNECTION, THE PATIENT NOTICED THAT THERE WAS A LEAK IN THE 0.22 UM FILTER. IT WAS REPORTED THAT THE LEAK DID NOT HAVE AN IMPACT ON THE TREATMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 8942330 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933390. One submission often covers many models, so check the product and lot details in each record.

• Z-2759-2017 · Dec 9, 2016 · Terminated
  Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.