NA 1C8109Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00085412031798), received between Oct 10, 2018 and Sep 22, 2026 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 reports).

12 other recalls cover devices cleared under the same FDA submission (K203609, K961225); 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Insufficient Flow or Under Infusion

  It was reported that an unspecified quantity of Solution Sets had infusion times approximately twice as long as expected. This occurred during 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 50850090 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A SOLUTION SET LEAKED FROM THE TUBING BELOW THE DRIP CHAMBER; SOLUTION SQUIRTED OUT OF THE LINE DUE TO A HOLE. THIS WAS OBSERVED DURING PRIMING WITH ZINECARD. A NEW BAG WAS REMADE TO CONTINUE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236921 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A BOND SEPARATION BETWEEN THE TUBING AND THE IN LINE BONDED COMPONENT (LUER LOCK END) OF A SOLUTION SET WHICH RESULTED IN A FLUID LEAK. WHEN ATTEMPTING TO CONNECT TO THE PATIENT¿S CENTRAL LINE, THE LUER LOCK END FELL OFF THE TUBING WHICH RESULTED IN MEDICATION LOSS (NOREPINEPHRINE). 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 25166942 ↗
• MalfunctionFeb 20, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE TUBING A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WHICH RESULTED IN A FLUID LEAK. DURING PATIENT INFUSION, IT WAS OBSERVED THAT THE TUBING WAS LEAKING FROM A CRACK. 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 24403890 ↗
• MalfunctionDec 11, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT A SOLUTION SET HAD NO PROTECTIVE CAP ON THE END OF THE LUER LOCK. THIS WAS DISCOVERED AFTER OPENING THE OUTSIDE PLASTIC WRAP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776745 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SOLUTION SET CAME APART IN A SPOT WHERE IT SHOULD NOT COME APART. THIS OCCURRED AFTER PRIMING AND DURING A CHECK PRIOR TO CONNECTING AND ADMINISTERING MEDICATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776587 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET LEAKED FROM BELOW THE DRIP CHAMBER. THIS OCCURRED DURING INFUSION OF PERIPHERAL PARENTERAL NUTRITION (PPN) MEDICATION IN THE PEDIATRIC DEPARTMENT. 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 23750852 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET BECAME DISCONNECTED FROM THE LUER LOCK, RESULTING IN AN OPEN SYSTEM. THIS OCCURRED DURING PATIENT INFUSION AT THE NEONATAL INTENSIVE CARE UNIT. 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 23691889 ↗
• InjurySep 5, 2025Break; Break

  IT WAS REPORTED A SOLUTION SET BROKE. WHEN THE MEDICAL STAFF ATTEMPTED TO PRESS THE BLUE SLIDE CLAMP INTO AN UNKNOWN BAXTER PUMP, THE CLAMP "BROKE IN HALF." THE PATIENT RECEIVED AN UNKNOWN VOLUME OF AN UNSPECIFIED "VASOPRESSIN BOLUS." IN TURN, THE PATIENT "BRIEFLY" BECAME HYPERTENSIVE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 22980814 ↗
• MalfunctionSep 4, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET LEAKED AT THE CONNECTION POINT OF THE SET AND A NON-BAXTER CHEMO LOCK. THIS OCCURRED WHILE PRIMING THE SET WITH AN UNSPECIFIED CHEMOTHERAPY AGENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964120 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET WAS SLICED AND LEAKED. THE WAS OBSERVED WHEN THE LINE WAS PLACED INTO THE PUMP AND CONNECTED TO THE PATIENT. THE DEVICE CONTAINED 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 22907833 ↗
• InjuryApr 28, 2025Disconnection; Disconnection

  IT WAS REPORTED A SOLUTION SET DISCONNECTED. THE PATIENT WAS POST CARDIAC ARREST AND WAS RECEIVING AN INFUSION OF EPINEPHRINE. THE TUBING WAS FOUND DISCONNECTED AT THE ¿HUB SITE¿. THE PATIENT WAS HYPOTENSIVE DURING THE EVENT. A NEW SOLUTION BAG HUNG AND THE TUBING SET WAS REPLACED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21923524 ↗
• MalfunctionMar 13, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A SOLUTION SET HAD A HOLE APPROXIMATELY 6-10 INCHES BELOW THE SPIKE AND ABOVE THE BLUE CLAMP RESULTING IN A LEAK OF SOLUTION ON THE FLOOR. THIS WAS NOTICED DURING PATIENT INFUSION OF POTASSIUM PHOSPHATE. 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 21597622 ↗
• MalfunctionFeb 7, 2025No Flow; No Flow

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF SOLUTION SETS WOULD NOT ALLOW FLUID TO FLOW EVEN WITH CLAMP OPEN. THESE OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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 21339476 ↗
• MalfunctionFeb 7, 2025No Flow; No Flow

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF SOLUTION SETS WOULD NOT ALLOW FLUID TO FLOW EVEN WITH CLAMP OPEN. THESE OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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 21339474 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET SNAPPED OFF FROM THE LEUR LOCK CONNECTION. THE LINE WAS A RUNNER LINE THAT CONTAINED REMIFENTANIL. THE LINE WAS CHANGED. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP DURING OR AFTER 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 20720031 ↗
• MalfunctionJul 1, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET WAS DRIPPING SOLUTION. THIS OCCURRED DURING PATIENT USE. THE HOLE IN THE TUBING WAS TAPED, AND THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AND TUBING WERE CLAMPED. THE SUPPLIES WERE REPLACED TO RESOLVE THE EVENT. 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 19651556 ↗
• MalfunctionJun 11, 2024Backflow; Break; Fluid/Blood Leak; Backflow; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET WAS LEAKING BLOOD THAT WAS BACKFLOWING FROM THE PATIENT AND INTO THE SET. BLOOD WAS OBSERVED TRAVELING UP THE ATTACHED/INFUSING HEPARIN LINE CONNECTED TO THE PATIENT'S LEFT FOREARM IV. THE HEPARIN INFUSION WAS STOPPED, AND UPON INSPECTION, THERE WERE MULTIPLE BREAKS IN THE LINE. 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 19515373 ↗
• MalfunctionMay 30, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET DISCONNECTED FROM THE PATIENT WHICH RESULTED IN A FLUID LEAK. THIS ISSUE OCCURRED DURING PATIENT INFUSION OF LIDOCAINE. 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 19427743 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SOLUTION SET LEAKED DURING PATIENT INFUSION. AFTER THE NURSE HUNG THE MEDICATION, THE TUBING DETACHED FROM THE PLASTIC COLLAR AND LEAKED. THE MEDICATION LEAKED ALL OVER THE FLOOR AND THE PATIENT. PROMPT CLEANUP OCCURRED. 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 18607208 ↗
• MalfunctionJan 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SOLUTION SET HAD BLACK FOREIGN MATERIAL EMBEDDED ON THE TUBING. FURTHER DESCRIBED AS, ¿IT LOOKED LIKE A BURN MARK THAT PUNCTURED THE TUBING¿. THIS WAS DISCOVERED UPON OPENING THE PRODUCT PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591976 ↗
• MalfunctionJul 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A SOLUTION SET LEAKED. THE NURSE PROGRAMED THE UNSPECIFIED INFUSION PUMP TO 100 MGL/HOUR¿. THE PATIENT WAS CONNECTED; HOWEVER, THE INFUSION OF OBINUTUZUMAB (290ML DILUTED IN 1000 MG UNSPECIFIED SOLUTION) HAD NOT YET BEEN STARTED WHEN THE SECOND NURSE OBSERVED THE FLUID ¿OUTSIDE OF BOTTOM OF THE DRIP CHAMBER AND NOTED TO BE RUNNING DOWN THE TUBING¿. 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 17351097 ↗
• MalfunctionJul 11, 2023No Flow; No Flow

  IT WAS REPORTED FOUR (4) SOLUTION SETS WOULD NOT FLOW. AT THE END OF THE INFUSIONS, THE NURSES 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 17302255 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET WAS LEAKING BEYOND THE END CAP WITH THE NEW HYDROPHOBIC FILTER. THE LEAK WAS OBSERVED WHEN CLOSING THE ROLLER CLAMP. THIS WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242305 ↗
• MalfunctionMar 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET WAS LEAKING FROM THE WHITE STOPPER/FILTER/CAP; LIQUID FLOWED BEYOND THE CAP. THIS WAS OBSERVED WHEN FILLING THE TUBE WITH IRON INTRAVENOUS (IV) SOLUTION. AN UNSPECIFIED FEMALE/MALE CONNECTOR PLUG WAS ADDED TO MAINTAIN STERILITY. 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 16529825 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203609, K961225. One submission often covers many models, so check the product and lot details in each record.

• Z-0194-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-0193-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-0192-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
• Z-2594-2025 · Aug 8, 2025 · Open, Classified
  Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration s
• Z-1011-2025 · Dec 20, 2024 · Open, Classified
  Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
• Z-0793-2020 · Dec 12, 2019 · Open, Classified
  Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vas
• Z-0794-2020 · Dec 12, 2019 · Open, Classified
  ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Pro
• Z-0475-2012 · Dec 6, 2011 · Terminated
  Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile
• Z-2920-2011 · Jul 21, 2011 · Terminated
  Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use
• Z-0653-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrog
• Z-0845-05 · Feb 28, 2005 · Terminated
  Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutio
• Z-1152-03 · Jul 16, 2003 · Terminated
  Interlink System Continu-Flo Solution Set with Microbore Tubing, 60 drops/mL, 128'', 3 injection sites, Male Luer Lock Adapter, catalog 2C6521; Baxter Healthcare Corporation, Deerf