NA 1C8363Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00085412013718), received between Sep 22, 2017 and Mar 9, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “No Flow” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K153158); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026No Flow

  IT WAS REPORTED THAT THE "FILTER ATTACHED TO BOTTOM OF PRIMARY LINE" OF AN EXTENSION SET WAS "DRY AND WOULD NOT ALLOW RE PRIMING". THE ISSUE OCCURRED DURING INFUSION. THE DEVICE WAS PRIMED WITH NORMAL SALINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553138 ↗
• MalfunctionOct 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT FOURTEEN (14) EXTENSION SETS HAD SLITS ON THE FILTER. THIS WAS DISCOVERED DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398255 ↗
• MalfunctionOct 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT FIFTEEN (15) EXTENSION SETS HAD SLITS ON THE FILTER. THIS WAS DISCOVERED DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398148 ↗
• MalfunctionApr 29, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AN EXTENSION SET ALLOWED BUBBLES TO PASS THROUGH THE FILTER. THIS WAS OBSERVED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209638 ↗
• MalfunctionFeb 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTENSION SET LEAKED FROM AN UNSPECIFIED LOCATION. THE DEVICE WAS USED FOR AROUND 15 HOURS TO RUN NON-LIPID PARENTERAL NUTRITION AFTER WHICH IT LEAKED. THIS OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672390 ↗
• MalfunctionOct 18, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOUR (4) EXTENSION SETS WERE FOUND WITH PARTICLES IN THE PACKAGING. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958654 ↗
• MalfunctionJul 11, 2023No Flow; No Flow

  IT WAS REPORTED AN EXTENSION SET WOULD NOT FLOW. AT THE END OF THE INFUSION, THE NURSE OBSERVED THE UNSPECIFIED SOLUTION WAS NOT FLOWING AND THE SPECTRUM PUMP IS NOT ALARMING ¿UPSTREAM OCCLUSION¿ EVEN THOUGH NO FLUID WAS MOVING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302571 ↗
• MalfunctionJun 8, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY [AT LEAST (50)] OF EXTENSION SETS HAD AIR. THERE WAS A SIGNIFICANT AMOUNT OF AIR IN THE FILTER PORTION OF THE ADD ON SET. THE ISSUES OCCURRED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17089717 ↗
• MalfunctionMar 31, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DURING EVALUATION OF A RETURNED UNUSED 0.22 MICRON EXTENSION SET, THE SET WAS FOUND TO HAVE A CUT IN THE STERILE PACKAGING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658446 ↗
• MalfunctionDec 28, 2021Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A CUT ON THE FILTER PACKAGING OF AN EXTENSION SET. THE ISSUE WAS IDENTIFIED DURING SELF CHECK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097928 ↗
• MalfunctionMay 15, 2020No Flow; No Flow

  IT WAS REPORTED THAT AN EXTENSION SET 0.22 MICRON DOWNSTREAM HIGH PRESSURE EXTENDED LIFE FILTER WOULD NOT FLOW; FURTHER DESCRIBED AS ¿THE FILTER BECOMES EMPTY¿. THIS ISSUE WAS IDENTIFIED DURING A PATIENT INFUSION. THE SET WAS BEING USED TO ADMINISTER DAE SOLUTION (DEXTOSE, AMINO ACID, ELECTROLYTES) AND RUNNING THE DAE AT A LOW RATE OF 6.9ML/HR. THE SET WAS IN USE WITH AN ANTI-REFLUX VALVE (NON-BAXTER) CONNECTED TO A 3-WAY STOPCOCK (NON-BAXTER). AFTER THE NURSE FIRST ENCOUNTERED THAT THE FILTER WAS EMPTY, THE EXTENSION SET WAS RE-PRIMED AGAIN WITH THE 3 WAY STOPCOCK DISCONNECTED AND THE FILTER WAS EMPTIED AGAIN AFTER FIVE MINUTES AND THE SET HAD TO BE RE-PRIMED A SECOND TIME. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063430 ↗
• MalfunctionMay 15, 2020No Flow; No Flow

  IT WAS REPORTED THAT AN EXTENSION SET 0.22 MICRON DOWNSTREAM HIGH PRESSURE EXTENDED LIFE FILTER SET WOULD NOT FLOW; FURTHER DESCRIBED AS ¿THE FILTER SET BECOMES EMPTY¿. THIS ISSUE WAS IDENTIFIED DURING A PATIENT INFUSION. THE SET WAS BEING USED TO ADMINISTER DAE SOLUTION (DEXTOSE, AMINO ACID, ELECTROLYTES) AND RUNNING THE DAE AT A LOW RATE OF 6.9ML/HR. THE SET WAS IN USE WITH A ANTI-REFLUX VALVE (NON-BAXTER) CONNECTED TO A 3-WAY STOPCOCK (NON-BAXTER). AFTER THE NURSE FIRST ENCOUNTERED THAT THE FILTER WAS EMPTY, THE EXTENSION SET WAS RE-PRIMED AGAIN WITH THE 3 WAY STOPCOCK DISCONNECTED AND THE FILTER WAS EMPTIED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063139 ↗
• InjurySep 22, 2017Chemical Spillage

  PATIENT RECEIVING ETOPOSIDE WITH BAXTER FILTER ATTACHED. PATIENT HAD CHEMO SPILLED UPON THEM AS IT WAS NOTED THAT THE FILTER WAS LEAKING.

  Patient problems: Chemical Exposure

  MAUDE report 6885892 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153158. One submission often covers many models, so check the product and lot details in each record.

• Z-0196-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2
• Z-0195-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8