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REPEATER H93887Recalls & reported problems

Baxter Corporation Englewood · REPEATER Pump Extension Set, Male LL to Male LL · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412476841), received between Mar 22, 2018 and Mar 6, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material3

Patient problems

  • No Patient Involvement3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THERE WAS A FIBER INSIDE AN UNOPENED STERILE PACKAGE OF A FLUID TRANSFER EXTENSION SET. THIS WAS IDENTIFIED DURING SETUP AND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Patient Involvement

    MAUDE report 9802015 ↗
  • MalfunctionJan 30, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT. IT WAS REPORTED THAT THERE WERE BLACK SPECKS IN THE MALE LUER LOCK OF A FLUID TRANSFER EXTENSION SET. THIS WAS NOTED PRIOR TO PRIMING THE SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Patient Involvement

    MAUDE report 8291141 ↗
  • MalfunctionMar 22, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT A BLACK PARTICLE WAS FOUND INSIDE THE MALE LUER LOCK CONNECTOR OF A FLUID TRANSFER EXTENSION SET. THIS OCCURRED DURING COMPOUNDING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Patient Involvement

    MAUDE report 7361451 ↗

Other Syringe, piston devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.