inforMED
MalfunctionFII

DIAPACT CRRT

Received Dec 6, 2007 · Event occurred Nov 16, 2007

Report 964903 · MDR key 964903

Device

Generic name

Dialysis Machine, Crrt

Model number

DIAPACT CRRT

Catalog number

*

Lot number

*

Product problems

  • Failure to Prime
  • Replace

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

NUMEROUS TUBING SETS FAILED TO PRIME IN THE B. BRAUN DIAPACT CRRT MACHINE. (THE HOSPITAL HAS FIVE OF THESE MACHINES DISTRIBUTED IN CRITICAL CARE AREAS). THE PROBLEM HAS BEEN SEEN ON SEVERAL OF THE FIVE MACHINES. UP TO NINE DIFFERENT TUBING SETS WERE USED UNTIL WE WERE ABLE TO GET THE UNIT PRIMED AND READY TO TREAT THE PATIENT. WE WERE TOLD BY THE B. BRAUN REP TO CONTINUE TO USE SETS UNTIL ONE WORKED. A SECOND LOT OF TUBING WAS BROUGHT IN BY B. BRAUN TO RESOLVE THE ISSUE AND THOSE ALSO EXPERIENCED THE SAME PROBLEM. B. BRAUN SUGGESTED THE ROLLERS IN THE DIAPACT CRRT MACHINES PUMPS REQUIRED REPLACEMENT. THE ROLLERS HAD JUST BEEN CHANGED BY BIOMEDICAL ENGINEERING ONE MONTH PRIOR TO THE START OF THIS ISSUE. THIS SUGGESTION WAS ELIMINATED AS A CAUSE FOR THE ISSUE. THIS WAS A GREAT DISTRACTION FROM THE CORE ISSUE, AND WASTED PRECIOUS TIME FOR RESOLUTION. B. BRAUN NOTIFIED US THAT THERE WERE NO MORE TUBING SETS OF A DIFFERENT LOT # IN THE UNITED STATES. THEY WERE FORCED TO SHIP A THIRD TUBING SET LOT FROM ITALY VIA BOAT. AT THE DISCUSSION OF THE SHIPPING OF THE THIRD TUBING SET LOT, B. BRAUN OFFERED TO SEND IN AN APPLICATIONS SPECIALIST TO ASSESS OPERATOR PERFORMANCE. THIS WAS SURPRISING AS ANY POTENTIAL FOR OPERATOR ERROR SHOULD HAVE BEEN ELIMINATED AT THE ONSET OF THIS PROBLEM. IT WAS ONLY AFTER THE THIRD LOT OF TUBING SETS ARRIVED THAT THE ISSUE WAS RESOLVED. WE CONTINUE TO MONITOR THE PERFORMANCE OF THESE UNITS TO ENSURE CONTINUED PROPER OPERATION, AND PERFORMANCE. TUBING SET LOT # 07I25 RESOLVED THE ISSUE. LOTS 07G04 AND 07G09 HAD THE PRIMING FAILURE. B. BRAUN SENT IN ONE LOANER MACHINE TO HAVE AVAILABLE TO BE PRIMED IN ADVANCE, READY FOR USE. THE IDEAL SITUATION WOULD BE TO HAVE TWO DIAPACT CRRT UNITS AVAILABLE, ONE FOR HEPARIN AND ONE NOT. B. BRAUN WOULD NOT FULLY ACCOMMODATE THIS REQUEST.