CADD 21-7057-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10610586020407), received between May 23, 2018 and Nov 19, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE NUTRIENT BAG AND CASSETTE ARE INSERTED INTO THE PUMP, NOTHING COMES OUT OF THE TUBE, AND IT GETS BLOCKED. THE CUSTOMER THEN TRIED DISCONNECTING AND INSERTING A NEW UNIT, AND THAT HAS WORKED AS IT SHOULD. 3 OUT OF 15 UNITES WERE AFFECTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593607 ↗
• MalfunctionNov 19, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE NUTRIENT BAG AND CASSETTE ARE INSERTED INTO THE PUMP, NOTHING COMES OUT OF THE TUBE, AND IT GETS BLOCKED. THE CUSTOMER THEN TRIED DISCONNECTING AND INSERTING A NEW UNIT, AND THAT HAS WORKED AS IT SHOULD. 3 OUT OF 15 UNITES WERE AFFECTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593598 ↗
• MalfunctionNov 19, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE NUTRIENT BAG AND CASSETTE ARE INSERTED INTO THE PUMP, NOTHING COMES OUT OF THE TUBE, AND IT GETS BLOCKED. THE CUSTOMER THEN TRIED DISCONNECTING AND INSERTING A NEW UNIT, AND THAT HAS WORKED AS IT SHOULD. 3 OUT OF 15 UNITES WERE AFFECTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593553 ↗
• MalfunctionAug 24, 2022Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection

  IT WAS REPORTED THAT DURING USE OF THE DEVICE IN THE PATIENT'S HOME, THERE WERE ISSUES WHEN PRIMING THE ADMINISTRATION TUBING SET. THE PUMP KEPT GIVING AN OCCLUSION ALARM WHEN PRIMING THE TUBING. ONCE THE TUBING SET WAS FINALLY FILLED THERE WAS NO PROBLEM WITH THE INFUSION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285662 ↗
• MalfunctionJun 18, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY ON USE, A SMITHS MEDICAL CADD ADMINISTRATION SET WAS NOTED TO HAVE A BROKEN DRIP UNIT AT THE PLUG ADAPTER. THE REPORTER INDICATED THAT IT WAS POINTED OUT THAT THE EVENT HAD A RISK OF AIR IN THE SYSTEM WITH CATASTROPHIC CONSEQUENCES FOR THE PATIENT IF NOT CAUGHT IN TIME. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024709 ↗
• MalfunctionFeb 22, 2021No Flow; No Flow

  INFORMATION WAS RECEIVED INDICATING THAT A NEW INFUSION OF TPN WITH A SMITHS MEDICAL CADD SOLIS VIP PUMP AND A CADD ADMINISTRATION SET WAS STARTED, THEN IT WAS NOTICED THAT THERE WAS BLOOD IN THE TUBE AND THE PUMP DID NOT DELIVER ANYTHING. IT WAS ALSO REPORTED THAT THE PUMP DID NOT ALARM. THE CLAMP WAS CLOSED AND THEN THE PUMP WAS CLOSED. THE CADD ADMINISTRATION SET WAS CHANGED AND THEN THE PUMP WORKED WELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11361473 ↗
• MalfunctionMay 23, 2018Collapse; Insufficient Flow or Under Infusion; Collapse; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE TUBING OF THE CADD ADMINISTRATION SET COLLAPSED DURING INFUSION. THIS IN TURN LED TO UNDER INFUSION. THE NURSE NOTED THAT THERE WAS MEDICATION LEFT IN THE BOTTLE AFTER APPROXIMATELY 1.5 HOURS. THE NURSE CHANGED THE TUBING AND THE MEDICATION RAN FINE ON THE NEW ADMINISTRATION SET. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7537112 ↗