REPEATER H93863Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00085412476698), received between May 21, 2020 and Nov 14, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TRIFURCATED FLUID TRANSFER TUBE SET LEAKED DURING FILLING RESULTING IN A PUDDLE UNDER THE PUMP. THE EVENT WAS FURTHER DESCRIBED AS "THE CONNECTION THAT LEAVES THE BAXA PUMP APPEARED TO BE LEAKING". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20690109 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Detachment of Device or Device Component; Fluid/Blood Leak; Loose or Intermittent Connection; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TRIFURCATED FLUID TRANSFER TUBE SET HAD THE FILTER OF A SPIKE KNOCKED OFF WHEN CHANGING A BAG OF SEMI-FINISHED PRODUCT. THIS OCCURRED DURING SETUP. ADDITIONALLY, THE HOSE CLAMP WAS NOT TIGHT ENOUGH AND THE BAGS EMPTIED THROUGH THE OPEN CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065148 ↗
• MalfunctionMay 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TRIFURCATED FLUID TRANSFER TUBE SET LEAKED UNSPECIFIED FLUID DESPITE THE CLAMP BEING CLOSED. THIS WAS DISCOVERED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862098 ↗
• MalfunctionApr 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TRIFURCATED FLUID TRANSFER TUBE SET LEAKED UNSPECIFIED FLUID DESPITE THE CLAMP BEING CLOSED. THIS WAS DISCOVERED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724385 ↗
• MalfunctionJul 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CLAMPS (SLIDE CLAMPS) TO CLOSE THE SPIKE END OF EACH OF THE THREE (3) TUBES ON A TRIFURCATED FLUID TRANSFER TUBE SET DID NOT STOP THE FLOW OF FLUIDS THROUGH THE TUBE WHICH RESULTED IN LEAKAGE ONTO THE SURFACE OF SPIKES THAT HAVE NOT YET BEEN USED AND SEEPAGE OF USED FLUIDS INTO OTHER LEADS AND THE FINAL FILLING TUBE. THIS WAS FURTHER DESCRIBED AS ¿THE SOLUTION WAS STILL RUNNING THROUGH THE LINE EVEN WITH CLAMPED PORTS¿. THE ISSUE WAS IDENTIFIED DURING A TRIAL TESTING PROCESS ON A BAXA PUMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108494 ↗
• MalfunctionMar 31, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF A TRIFURCATED FLUID TRANSFER TUBE SET WAS DAMAGED. THERE WAS A SMALL HOLE FOUND IN THE PACKAGING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13970641 ↗
• MalfunctionOct 20, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE CLAMPS OF AN UNSPECIFIED NUMBERS OF TRIFURCATED FLUID TRANSFER TUBE SETS WERE NOT PREVENTING LIQUIDS FROM FLOWING FROM ONE BAG TO ANOTHER. IT WAS FURTHER REPORTED THAT USUAL SPEED WAS USED ON THE PUMP AND THE AMOUNT OF FLUID TRANSFER WAS NOT MORE THAN IT SHOULD BE. THIS ISSUE WAS IDENTIFIED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669280 ↗
• MalfunctionOct 11, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CLAMPS OF AN UNSPECIFIED QUANTITY OF TRIFURCATED FLUID TRANSFER TUBE SETS WERE NOT PREVENTING LIQUIDS FROM FLOWING FROM ONE BAG TO ANOTHER. IT WAS FURTHER REPORTED THAT USUAL SPEED WAS USED ON THE PUMP AND THE AMOUNT OF FLUID TRANSFER WAS NOT MORE THAN IT SHOULD BE. THIS ISSUE WAS IDENTIFIED WHILE PREPARING SOLUTIONS DURING ¿SERVICE/TESTING¿. THE DEFECTIVE TUBING SETS WERE CHANGED. 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 12609103 ↗
• MalfunctionSep 14, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT (20) TRIFURCATED FLUID TRANSFER TUBE SETS HAD HOLES IN THE OVERPOUCH. IT WAS FURTHER REPORTED THAT THERE WAS NO DAMAGED TO THE SHIPPING CARTON. THIS ISSUE WAS IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468117 ↗
• MalfunctionAug 9, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT AT LEAST FIVE (5) TRIFURCATED FLUID TRANSFER TUBE SETS WERE BREAKING DURING COMPOUNDING. THE EVENT WAS FURTHER DESCRIBED AS THE TUBING DOES NOT STICK WITH THE NORMAL SALINE BAG AND SUDDENLY DETACHED FROM THE BAG IN THE MIDDLE OF COMPOUNDING. NO CRACKS WERE OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294208 ↗
• MalfunctionJul 1, 2021Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THE TUBING AT THE JUNCTION OF THE TRIFURCATED AND REGULAR TUBING ON TWO (2) TRIFURCATED FLUID TRANSFER TUBE SETS ¿WAS BREAKING OFF¿ (SEPARATED). THE ISSUE WAS IDENTIFIED ¿DURING SET UP POST SPIKING THREE BAGS JUST PRIOR TO TUBING SET EXITING BSC¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103905 ↗
• MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF TRIFURCATED FLUID TRANSFER TUBE SETS LEAKED. THE LEAKS OCCURRED EVEN THOUGH THE CLIPS WERE FULLY ENGAGED. THE SETS WERE USED WITH STERILE WATER AND/OR SODIUM CHLORIDE (NACL). THE FLUIDS WERE BLEEDING INTO EACH OTHER OR LEAKING OUT OF THE LINE FROM THE ONE THAT WAS DISCONNECTED. THIS WAS IDENTIFIED DURING SETUP, AFTER ENTERING THE BAGS FOR DISPENSING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018067 ↗
• MalfunctionJun 8, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A TRIFURCATED FLUID TRANSFER TUBE SET HAD A HOLE IN THE PACKAGING. THIS WAS IDENTIFIED BEFORE USE. IT WAS FURTHER REPORTED THE PRODUCT WAS NOT DAMAGED DURING THE UNPACKING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962837 ↗
• MalfunctionMar 10, 2021Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE TUBING OF THE UNSPECIFIED QUANTITY OF TRIFURCATED FLUID TRANSFER TUBE SETS BREAK AT THE SPIKE PORT. DURING COMPOUNDING, THE SPIKE WOULD BEGIN TO LOOSEN AND THEN THE TUBING WOULD SNAP. THIS EVENT OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453857 ↗
• MalfunctionMar 8, 2021Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE TUBING OF A TRIFURCATED FLUID TRANSFER TUBE SET BROKE AT THE SPIKE PORT. THE SPIKE BEGAN TO LOOSEN AND THEN THE TUBING SNAPPED. THIS OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11438952 ↗
• MalfunctionNov 11, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT HOLES WERE OBSERVED IN THE STERILE PRIMARY PACKAGING OF THREE (3) TRIFURCATED FLUID TRANSFER TUBE SETS. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS ON PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10825643 ↗
• MalfunctionJul 28, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT ¿AT LEAST ONE OF THE THREE SPIKES¿ OF A TRIFURCATED FLUID TRANSFER TUBE SET DETACHED FROM THE TUBING CAUSING A LEAK. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10335681 ↗
• MalfunctionJul 28, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT LEAST ONE OF THE THREE SPIKES OF A TRIFURCATED FLUID TRANSFER TUBE SET DETACHED LEADING TO A LEAK. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10333008 ↗
• MalfunctionJul 28, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO OF THE THREE SPIKES OF A TRIFURCATED FLUID TRANSFER TUBE SET DETACHED LEADING TO A LEAK. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10332974 ↗
• MalfunctionJul 7, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT SIX (6) TRIFURCATED FLUID TRANSFER TUBE SETS HAD DEFECTIVE HEAT SEALS LEADING TO A LOSS OF STERILITY. THIS WAS IDENTIFIED DURING AN UNSPECIFIED STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10242815 ↗
• MalfunctionJun 5, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AT LEAST 1 TRIFURCATED FLUID TRANSFER TUBE SET LEAKED FROM A TEAR ON THE TUBING WHICH WAS THREADED AROUND THE ROTOR. IT WAS FURTHER REPORTED THAT THE PUMP WAS SETUP UP WITH THE PORT OF THE TUBING CONNECTED TO A 1L 0.9% NORMAL SALINE BAG AND THE OUTLET END OF THE TUBING WAS SETUP WITH AN 18 GAUGE NEEDLE. THE PUMP SETTING WAS ON HIGH 7. THIS ISSUE WAS IDENTIFIED DURING PREPARATION OF AN EMPTY BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10125147 ↗
• MalfunctionJun 5, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AT LEAST 1 TRIFURCATED FLUID TRANSFER TUBE SET LEAKED FROM A TEAR ON THE TUBING WHICH WAS THREADED AROUND THE ROTOR. IT WAS FURTHER REPORTED THAT THE PUMP WAS SETUP UP WITH THE PORT OF THE TUBING CONNECTED TO A 1L 0.9% NORMAL SALINE BAG AND THE OUTLET END OF THE TUBING WAS SETUP WITH AN 18 GAUGE NEEDLE. THE PUMP SETTING WAS ON HIGH 7. THIS ISSUE WAS IDENTIFIED DURING PREPARATION OF AN EMPTY BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10125125 ↗
• MalfunctionJun 2, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE STERILE PRIMARY PACKAGING OF A TRIFURCATED FLUID TRANSFER TUBE SET WAS DAMAGED. THE DAMAGE WAS FURTHER DESCRIBED AS THE HEAT SEAL OF THE OUTER PACKAGING CAME APART WHEN THE PACKAGING WAS MANIPULATED. THIS ISSUES WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10112249 ↗
• MalfunctionMay 21, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT FOUR (4) TRIFURCATED FLUID TRANSFER TUBE SETS HAD HEAT SEALS ON THE PACKAGING THAT CAME APART. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10080038 ↗