REPEATER H93811Recalls & reported problems
Baxter Healthcare Corporation · Sterile REPEATER Pump Tube Sets, Universal Spike - Luer Lock · Class 2
Quick summary
This Baxter REPEATER pump tube set is a sterile IV fluid transfer set. All 164 of its adverse event reports are malfunctions, with no injuries and no deaths. Many describe fluid or saline leaking at connection points, and others describe tubes disconnecting, breaking, or sticky tape residue contaminating the set. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 165
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 00085412475721), received between Jan 22, 2018 and Sep 29, 2026 — classified as 165 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (84 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak84
- Disconnection38
- Device Contamination with Chemical or Other Material29
- Break19
- Air/Gas in Device10
- Detachment of Device or Device Component5
- Loose or Intermittent Connection5
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions112
- No Patient Involvement49
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934444 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781697 ↗MalfunctionSep 13, 2026Fluid/Blood Leak; No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747677 ↗MalfunctionAug 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229246 ↗MalfunctionJun 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT NINE (9) STERILE REPEATER PUMP TUBE SETS LEAKED AT THE CONNECTION POINT BETWEEN THE TUBING AND THE PUMP CONNECTORS (BLUE PLASTIC PIECE). THIS OCCURRED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25407664 ↗MalfunctionApr 30, 2026Air/Gas in Device
IT WAS REPORTED THAT AIR WAS LEAKING INTO THE LINES OF A STERILE REPEATER PUMP TUBE SET. DURING COMPOUNDING, LARGE AIR BUBBLES WERE OBSERVED IN A COUPLE OF THE NON BAXTER UNITS WHILE BEING FILLED WITH NORMAL SALINE. AFTER CHANGING THE SET, THEY DID NOT EXPERIENCE THIS ISSUE AGAIN. THIS ISSUE WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25052508 ↗MalfunctionApr 20, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) STERILE REPEATER PUMP TUBE SETS LEAKED. THE LOCATION OF THE LEAK WAS DESCRIBED AS "THE BACK END ON THE IV BAG SIDE WHERE THE TUBING ENTERS INTO THE REPEATER PUMP." THIS ISSUE WAS IDENTIFIED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933774 ↗MalfunctionApr 14, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET LEAKED NORMAL SALINE (NS) DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24880093 ↗MalfunctionMar 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET HAD A SMALL LEAK BETWEEN THE CLAMP AND TUBING. THE ISSUE WAS IDENTIFIED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24576355 ↗MalfunctionMar 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SETS LEAKED DRUG IN THE "FLOW RATE CONTROL CLAMP". THE ISSUE WAS NOTICED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567988 ↗MalfunctionMar 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) STERILE REPEATER PUMP TUBE SETS LEAKED AT THE JUNCTION. THIS WAS OBSERVED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532533 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) STERILE REPEATER PUMP TUBE SETS LEAKED BETWEEN THE CLAMP AND TUBING. THIS WAS OBSERVED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497431 ↗MalfunctionMar 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET LEAKED BETWEEN THE CLAMP (PUMP CONNECTORS) AND THE TUBING. THIS OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489984 ↗MalfunctionFeb 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) STERILE REPEATER PUMP TUBE SETS LEAKED BETWEEN THE CLAMP (PUMP CONNECTORS) AND THE TUBING. ONE ISSUE OCCURRED DURING COMPOUNDING, WHILE TWO OCCURRED DURING TESTING OF THE AFFECTED BATCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471981 ↗MalfunctionFeb 27, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT TEN (10) STERILE REPEATER PUMP TUBE SETS HAD BLACK PARTICLES ON THE HOSE AREA. THE PARTICLES APPEARED TO BE FIXED. THIS WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467570 ↗MalfunctionFeb 26, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) STERILE REPEATER PUMP TUBE SETS LEAKED BETWEEN THE CLAMP (PUMP CONNECTORS) AND TUBING. THIS OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461057 ↗MalfunctionFeb 20, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET LEAKED BETWEEN CLAMP AND THE TUBING. THIS OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399718 ↗MalfunctionJan 13, 2026Fluid/Blood Leak; Component Missing
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET LEAKED FROM A MISSING ¿DIAPHRAGM¿. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054520 ↗MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) STERILE REPEATER PUMP TUBE SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872417 ↗MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET WAS LEAKING FROM THE VENTILATION HOLE. THE LEAK WAS DISCOVERED AFTER CONNECTING THE INTRAVENOUS BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865556 ↗MalfunctionDec 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT TEN (10) STERILE REPEATER PUMP TUBE SETS HAD PARTICULATE MATTER IN AN UNSPECIFIED LOCATION. THE PARTICULATE WAS DESCRIBED AS DARK PARTICLES AND FIBER. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688480 ↗MalfunctionDec 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT EIGHT (8) STERILE REPEATER PUMP TUBE SETS HAD PARTICULATE MATTER IN AN UNSPECIFIED LOCATION. THE PARTICULATE WAS DESCRIBED AS DARK PARTICLES AND FIBER. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688472 ↗MalfunctionDec 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT EIGHT (8) STERILE REPEATER PUMP TUBE SETS HAD PARTICULATE MATTER IN AN UNSPECIFIED LOCATION. THE PARTICULATE WAS DESCRIBED AS DARK PARTICLES AND FIBER. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688467 ↗MalfunctionOct 29, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT THE VALVE LID OF A STERILE REPEATER PUMP TUBE SET FELL OFF WHICH RESULTED IN A FLUID LEAK. THIS ISSUE WAS DESCRIBED AS, ¿TRIED TO OPEN THE VALVE LID TO LOWER THE PRESSURE, THE ENTIRE VALVE FALLS OUT, RESULTING IN A LEAK¿. THIS ISSUE OCCURRED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417374 ↗MalfunctionOct 28, 2025Complete Blockage; Failure to Infuse; Complete Blockage; Failure to Infuse
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET WAS BLOCKED, NOT ALLOWING THE FLUID TO PASS THROUGH THE TUBE. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409589 ↗
Other Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.