REPEATER H93821Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00085412476520), received between Apr 19, 2019 and Sep 17, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808665 ↗
• MalfunctionDec 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SIX (6) REPEATER PUMP FLUID TRANSFER TUBE SETS HAD FOREIGN PARTICLES IN THE PRODUCT CONTAINER. THIS WAS NOTICED BEFORE PRODUCT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023323 ↗
• MalfunctionJun 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED UNSPECIFIED PARTICULATE WAS OBSERVED IN THREE (3) FLUID TRANSFER TUBE SETS. DURING DILUTION OF CEFUROXINS WHAT APPEARED TO BE ¿SMALL PIECES OF PLASTIC AND DUST¿ WERE NOTED AT THE ¿THICKER END OF THE LUER LOCK TUBE¿. THE FIRST TUBE HAD THE MOST PARTICULATE. THE SECOND TUBE HAD FEWER, BUT ¿BIGGER NUGGETS¿. THE THIRD ¿HAD QUITE A FEW¿. THE EVENT OCCURRED DURING HANDLING IN PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581926 ↗
• MalfunctionJun 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER CONTAMINATION WAS OBSERVED IN THE TUBING OF THREE (3) REPEATER PUMP FLUID TRANSFER TUBE SETS. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿PARTICLES WERE FOUND TO BE PRESENT AT THE THICKER END OF THE LL TUBE (AS IF MIXING SMALL PIECES OF PLASTIC AND DUST)¿ AND ¿THE FIRST HOSE HAD THE MOST, THE SECOND FEWER, BUT BIGGER NUGGETS, AND THE THIRD HAD QUITE A FEW¿. THIS ISSUE WAS DISCOVERED DURING HANDLING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577231 ↗
• MalfunctionMar 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER INSIDE THE PACKAGING OF A STERILE REPEATER PUMP TUBE SET. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817171 ↗
• MalfunctionJun 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A FLUID TRANSFER TUBE SET LEAKED CLOSE TO THE CONNECTION OF A REPEATER PUMP. THE ISSUE WAS IDENTIFIED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203582 ↗
• MalfunctionJun 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A FLUID TRANSFER TUBE SET LEAKED CLOSE TO THE CONNECTION OF THE REPEATER PUMP. THE ISSUE OCCURRED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199355 ↗
• MalfunctionApr 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) FLUID TRANSFER TUBE SETS WERE LEAKING. THIS EVENT OCCURRED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765371 ↗
• MalfunctionAug 3, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE LUER LOCK OUTLETS OF A THIRTEEN (13) FLUID TRANSFER TUBE SETS "TURNED YELLOWISH". THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157043 ↗
• MalfunctionJan 4, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF A FLUID TRANSFER TUBE SET WAS DAMAGED. THE EVENT WAS FURTHER DESCRIBED AS; UNCOVERED (OPEN) DEVICE IS DETECTED, WITHOUT THE SECURITY SEAL. THIS ISSUE WAS IDENTIFIED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155357 ↗
• MalfunctionDec 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A REPEATER PUMP FLUID TUBE SET LEAKED AT THE ¿MIDDLE SEPARATOR OF THE TWO TUBES¿. THIS OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052640 ↗
• MalfunctionNov 22, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A FLUID TRANSFER TUBE SET LEAKED AND ¿HAS BEEN TORN¿. THE EVENT WAS FURTHER DESCRIBED AS DURING USE FOR FILTERING CASTOR OIL THROUGH A 0.2 MICRON FILTER, THE TRANSFER SET HAS BROKEN AT THE LEVEL OF THE ROTOR". THE DEVICE WAS BEING USED WITH A BAXA REPEATER PUMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851978 ↗
• MalfunctionAug 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A FLUID TRANSFER TUBE SET LEAKED AT THE JOINT OF THE TUBE AND THREADED CONNECTOR. THIS WAS IDENTIFIED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380310 ↗
• MalfunctionMay 24, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLUID TRANSFER TUBE SETS FAILED QUALITY TESTING. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿THERE WAS TOO MUCH ENDOTOXIN ON THE LOTS¿. THIS EVENT WAS OBSERVED DURING LAB TESTING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872457 ↗
• MalfunctionMay 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A FLUID TRANSFER TUBE SET WAS LEAKING WITH UNSPECIFIED MEDICINE. THE LEAK WAS COMING FROM THE WHITE AREA OF THE SET THAT FITS INTO THE PUMP. A NEW SET WAS REPLACED AND THE ISSUE RESOLVED. THIS ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811896 ↗
• MalfunctionDec 17, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE WRAPPER SEALS OF FOUR UNITS OF FLUID TRANSFER TUBE SETS WERE FOUND TO BE OPENED. THIS WAS IDENTIFIED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9483171 ↗
• MalfunctionNov 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A REPEATER PUMP TUBE SET WAS LEAKING. IT WAS FURTHER REPORTED THAT THE LEAK WAS OBSERVED AT ONE OF THE BLUE CONNECTIONS RESULTING IN LOSS OF PRODUCT. THIS ISSUE WAS IDENTIFIED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9306642 ↗
• MalfunctionApr 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT TWO (2) REPEATER PUMP TUBE SETS WERE LEAKING. THE LEAKS WERE OBSERVED FROM THE CONNECTION OF THE PLASTIC CLOSE TO THE LUER CONNECTION OF THE LINE. FOR BOTH EVENTS, THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8533695 ↗
• MalfunctionApr 19, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS. IT WAS REPORTED THAT NINE REPEATER PUMP TUBE SETS HAD PARTICULATE MATTER. IN EIGHT OF THE EVENTS, THE PARTICULATE MATTER WAS OBSERVED INSIDE THE TUBING. IN ONE EVENT, THE PARTICULATE MATTER WAS FURTHER DESCRIBED AS A HAIR INSIDE THE PACKAGING. FOR ALL NINE OF THE EVENTS, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8533669 ↗