Start-Up Kit CG-500DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00849111075329), received between Jan 22, 2016 and Dec 12, 2017 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K014241); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A PATIENT WAS HOSPITALIZED IN ICU AND AN IVTM WAS NEEDED. A ZOLL QUATTRO CATHETER PLACED A DAY BEFORE THE PATIENT WAS TAKEN TO CATH LAB. DURING PROCEDURE IN THE CATH LAB, THE CUSTOMER NOTED BLOOD IN THE START-UP KIT (SUK) AND SALINE BAG. THE CATHETER WAS REMOVED AND THE PATIENT WAS PLACED ON ARCTIC SUN. THE CATHETER BREACH WAS LIKELY CAUSED BY THE PROCEDURE/PCI. THE CUSTOMER WAS NOT SUPPOSED TO BE UTILIZING THE QUATTRO CATHETER, AS THEY HAVE NOT HAD THEIR OFFICIAL 'GO-LIVE'. NO KNOWN PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7109336 ↗
• MalfunctionNov 13, 2017Leak/Splash; Leak/Splash

  A PATIENT WAS HOSPITALIZED POST CARDIAC ARREST AND AN INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) WAS NEEDED. A ZOLL QUATTRO CATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN AND THE IVTM THERAPY WAS INITIATED AT 11PM ON (B)(6) 2017. THE INSERTION WAS SMOOTH. THE PATIENT'S TEMPERATURE PRIOR TO THE IVTM THERAPY WAS 37.2 DEGREE CELSIUS. THE TARGET TEMPERATURE ON THE CONSOLE WAS 33 DEGREE CELSIUS. DURING THERAPY, AN AIR TRAP ALARM WAS NOTED. THE ATTENDING NURSE CHANGED THE SALINE BAG AND THE AIR TRAP ALARM WAS CLEARED. 7.5 HOURS INTO THE THERAPY, BLOOD WAS NOTED IN THE START-UP KIT (SUK). THE CATHETER WAS REPLACED AND THERAPY WAS RESUMED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7026472 ↗
• MalfunctionOct 26, 2017Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  AS REPORTED, PHYSICIAN EXPERIENCED DIFFICULTY REMOVING GUIDEWIRE FROM CATHETER WHEN ATTEMPTING TO PLACE A QUATTRO CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. DATE AND TIME OF THE INCIDENT IS UNKNOWN. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982063 ↗
• MalfunctionNov 4, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A FEMALE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR POST- ARREST HYPOTHERMIA. THE COOLING PROCEDURE STARTED ON (B)(6) 2016 AND STOPPED ON (B)(6) 2016. THERE WERE NO OTHER TEMPERATURE MANAGEMENT PROCEDURES PERFORMED ON THE PATIENT. AN ICY CATHETER WAS INSERTED IN THE RIGHT FEMORAL VEIN. THERE WERE NO ISSUES DURING SET UP AND PRIMING. BEFORE CONNECTING THE SUK TO PATIENT, IT WAS IMMEDIATELY NOTICED THAT THE SUK ORANGE LUER MALE CONNECTOR WAS FOUND TO BE BROKEN. THE SUK WAS REMOVED AND ANOTHER SUK WAS USED. IT WAS ABLE TO CONNECT TO SYSTEM SUCCESSFULLY. THE THERAPY WAS CONTINUED AND COMPLETED. PER REPORTER, THE FAMILY MADE THE DECISION TO CONTINUE WITH COMFORT MEASURES ONLY AND WITHDRAW CARE WHEN SHE DID NOT WAKE UP AFTER COMPLETION OF TREATMENT. THE PATIENT EXPIRED ON (B)(6) 2016. THE CAUSE OF DEATH WAS NOT PROVIDED AND THE DEATH WAS NOT ATTRIBUTED TO THE DEVICE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6080559 ↗
• MalfunctionSep 29, 2016Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SUK PIN-SIZED HOLE IN TUBING LEAKING AND THE LIQUID WAS FOUND ON THE PATIENT BED. THERE WAS NO ISSUE GETTING CONSOLE STARTED. A NEW START-UP KIT WAS REPLACED AND THE THERAPY WAS CONTINUED AND COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED FROM MEDWATCH STATING THAT RN NOTED PT'S BED LINENS WERE SATURATED. UPON INSPECTION OF THE COOL LINE TUBING IT REVEALED A CRACK IN THE TUBING AT THE CONNECTION SITE TO THE ACTUAL QUATTRO CATHETER. THE ORIGINAL PROCEDURE WAS INTENDED TO MAINTAIN NORMOTHERMIA FOR TRAUMATIC BRAIN INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5988068 ↗
• MalfunctionMar 15, 2016Device Issue; Device Operates Differently Than Expected; Device Issue; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THERAPEUTIC TREATMENT WITH THE IVTM THERMOGARD SYSTEM A LEAK WAS OBSERVED. THE TREATMENT WAS ON A MALE PATIENT, (B)(6), WEIGHING (B)(6) WHO WAS HOSPITALIZED TO BE TREATED FOR NORMOTHERMIA. THE PATIENT'S TEMPERATURE PRIOR TO IVTM THERAPY WAS 42.1 DEGREES CELSIUS. THERE WERE NO ADJUNCT TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT. THE ICY CATHETER WAS INSERTED BY AN EXPERIENCED PHYSICIAN INTO THE LEFT FEMORAL VEIN. THE INSERTION WAS DIFFICULT, HOWEVER IT WAS MADE IN ONE ATTEMPT. THE DWELL TIME THE CATHETER WAS KEPT IN THE PATIENT FOR 15 MINUTES. IT WAS OBSERVED, AFTER 2 MINUTES, THAT THE SALINE BAG WAS EMPTY. NO LEAKS WERE OBSERVED ON THE PATIENT OR ON THE BED. IT WAS ASSUMED THAT 750ML OF SALINE SOLUTION WENT INTO THE PATIENT. IT WAS REPORTED THAT AN AIR TRAP ALARM SOUNDED, BUBBLES WERE SEEN IN THE SYSTEM, AND THE CATHETER WAS REPLACED; HOWEVER THE TREATMENT WAS DISCONTINUED. IT WAS REPORTED THAT THE PATIENT EXPIRED AS A RESULT OF HIS ENCEPHALITIS. REFERENCE: MFR 3010617000-2016-00166.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5502016 ↗
• MalfunctionFeb 27, 2016Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PATIENT TREATMENT THE HOSPITAL STAFF OBSERVED A WATER LEAK IN THE IVTM THERMOGARD XP AIR TRAP SYSTEM. THE LEAK APPEARED TO BE INITIATED AT THE JOIN OF THE AIR TRAP CYLINDER AND THE LID. THE WATER FLOODED THE THERMOGARD XP. PATIENT THERAPY WAS INTERRUPTED. THE PATIENT WAS A (B)(6) MALE, WEIGHING (B)(6) WHO WAS HOSPITALIZED FOR POST CARDIAC ARREST. THE REASON FOR THERAPEUTIC IVTM WAS FOR THERAPEUTIC HYPOTHERMIA. THERE WERE NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT. A ZOLL CATHETER WAS SUCCESSFULLY PLACED INTO THE RIGHT FEMORAL VEIN. CATHETER INSERTION WAS MADE IN ONE ATTEMPT. THE INSERTION WAS SMOOTH BY AN EXPERIENCED PHYSICIAN. THE CONSOLE WAS SET TO MAX MODE. THE PATIENT TEMPERATURE AT THE START OF THERAPY WAS 34.9 DEGREES CELSIUS. THE TARGET TEMPERATURE SET POINT ON THE CONSOLE WAS 33.0 DEGREES CELSIUS. THE REPORTED ISSUE WAS OBSERVED, 30 MINUTES INTO THERAPY WHEN THE PATIENT'S TEMPERATURE WAS 33.1 DEGREES CELSIUS. THE WARMING RATE FOR THERAPY HAD NOT STARTED. THE DWELL TIME THE CATHETER WAS KEPT IN THE PATIENT WAS APPROXIMATELY 26 HOURS. THE SUK WAS REPLACED, TREATMENT WAS COMPETED. THERE WERE NO SYSTEM ALARMS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5465270 ↗
• InjuryJan 22, 2016Device Issue; Device Issue

  IT WAS REPORTED THAT DURING PATIENT TREATMENT FOR NORMOTHERMIA WITH THE ZOLL QUATTRO CATHETER, THE MEDICAL PERSONNEL HAD DIFFICULTY REMOVING THE CATHETER FROM THE PATIENT. THE CATHETER WAS INSERTED WITHOUT ANY ISSUES BY AN EXPERIENCED PHYSICIAN. THE PATIENT WAS COOLED SUCCESSFULLY. THE DWELL TIME OF THE CATHETER WAS 20 DAYS. DURING REMOVAL OF THE CATHETER, THE NURSE DEFLATED THE BALLOONS AND TRIED TO PULL THE CATHETER OUT BUT MET RESISTANCE. THEY HAD ATTEMPTED TO ASPIRATE THE SALINE PRIOR TO REMOVAL. THEY SCANNED THE PATIENT TO VIEW THE CATHETER AND FOUND THAT THE THREE DISTAL BALLOONS DID NOT DEFLATE. VASCULAR SURGEON PERFORMED A SURGICAL INTERVENTION TO PUNCTURE HOLES INTO THE THREE REMAINING BALLOONS TO FACILITATE REMOVAL. THE EVENT WAS RESOLVED WITHOUT SEQUELAE. NO PATIENT INFORMATION WAS DISCLOSED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5385506 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014241. One submission often covers many models, so check the product and lot details in each record.

• Z-0503-2007 · Jan 1, 2007 · Terminated
  Alsius Cool Line Catheter, Model CL-2295AE
• Z-0502-2007 · Jan 1, 2007 · Terminated
  Alsius Cool Line Catheter, Model CL-2295A
• Z-0369-06 · Nov 9, 2005 · Terminated
  Alsius CoolGard Temperature Regulation System
• Z-1397-05 · Jul 25, 2005 · Terminated
  Alsius CoolGard 3000 Temperature Regulation System
• Z-0258-05 · Nov 10, 2004 · Terminated
  Alsius CoolGard 3000 patient temperature regulation system
• Z-1159-04 · Jun 21, 2004 · Terminated
  Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000