FDA Adverse Event Death Summary report: N

DRAKE WILLOCK

MDR report key: 18858 · Received October 26, 1994

Report

Report Number
2243621-1994-00401
Event Type
Death
Date Received
October 26, 1994
Date of Event
September 7, 1994
Report Date
September 12, 1994
Manufacturer
ALTHIN CD MEDICAL, INC.
Product Code
FKQ
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
MA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

DIALYSIS FACILITY OPERATES AND CONTROL DELIVERY SYSTEMS DURING THE DAY SHIFT. ONLY ONE CENTRAL NEEDED ON EVENING SHIFT. AT 6 PM WHILE SIX PTS WERE DIALYZING, THE WRONG VCENTRAL WAS PLACED IN TE MODE/ THE SIX PTS DIALYZED AGAINST ACID CONCENTRATE AND RO WATER FOR APPROX. THREE MINUTES. THE PTS COMPLAINED OF SEVERE CRAMPING AND CHEST PAINS. MISTAKE REALIZED. SYSTEM PLACED IN BYPASS. ALL TREATMENTS TERMINATED. BLOOD RETURNED. TREATMENTS AFTER CENTRAL PLACED BACK IN CORRECT MODE AND CONDUCTIVIY CAME INTO RANGE.TREATMENT RESTARTED AT 6:30 PM ONATIENT S.C. BP 144/64. PT COMPLAINED OF NAUSEA AT 6:50 PM. REFLAN 5MG GIVEN IV. BP 124/62. BLOOD SUGAR 120, OXYGEN INITIATED AT 2L/MIN. BP 162/62 AND 170/64 UPON 1/2 HR CHECKS. PT SEEN BY PHYSIANATAPPROX 8 PM. AT 8:10 PT STILL COMPLAINING OF NAUSEA AFTER TREATMENT TERMINATED (8:05) SECOND DOSE OF REFLAN 5MG IV GIVEN.PT INSTRUCTED THAT NAUSEA WAS LIKELY CAUSED BY DIALYSIS WITH A BATCH OF LOW CONDUCTIVITY AND TO AVOID HIGH POTASSIUM FOODS. PT ALSO INSTRUCTED TO CALL PHYSICIAN IF NAUSEA WORSENED OR NEW SYMPTOMS DEVELOPED.UPON RETURING HOE, PT COMPLAINED OF CHILLS AND NAUSEA, TOOK AN ANTIEMETRIC SUPPOSITORY AND WENT TOBED. SEVERAL HHRS LATER, PT'S HUSBAND FOUND PT WITHOUT PULSE OR RESPIRATION AND CALLED RESCUE. RESCUE UNABLE TO REVIVE PT.FOUR OF THE SIX OTHER PTS DIALYZED THE NEXT DAAY. NONE OF THE OTHER PTS EXPERIENCED PERMANENT INJURY.HUMAN ERROR DETERMINED AS CAUSE FOR INCIDENT NOT DEVICE FAILURE.PHYSICIAN UNSURE IF EVENT CONTRIBUTED TO PT'S DEATH SINCE PT HAD MULTIPLE CONDITIONS. CRELATION BELIEVED TO BE UNLIKELY, BUT COULD NOT DEFINITELY BE RULED OUT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DRAKE WILLOCK CENTRAL DELIVERY SYSTEM - DIALS FKQ ALTHIN CD MEDICAL, INC. 4009-1

Patients

Seq Age Sex Outcome Treatment
1 43 YR Death NMC CENTRALYTE ACID & BICARB