FDA Adverse Event Death Summary report: N

DRAKE WILLOCK

MDR report key: 17044 · Received September 12, 1994

Report

Report Number
17044
Event Type
Death
Date Received
September 12, 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
User Facility report
Reporter Location
MA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

DIALYSIS FACILITY OPERATES 2 CENTRAL DELIVERY SYSTEMS DURING THE DAY SHIFT. ONLY ONE CENTRAL NEEDED ON EVENING SHIFT. AT 6:00 PM WHILE 6 PTS WERE DIALYZING, THE WRONG CENTRAL DELIVERY SYSTEM WAS PLACED IN THE RINSE MODE. THE 6 PTS DIALYZED AGAINST ACID CONCENTRATE AND WATER FOR APPROXIMATELY 3 MINUTES. THE PTS COMPLAINED OF SEVERE CRAMPING AND CHEST PAINS. MISTAKE REALIZED. SYSTEM PLACED IN BYPASS. ALL TREATMENTS TERMINATED. BLOOD RETURNED. TREATMENTS RESUMED AFTER CENTRAL PLACED BACK IN CORRECT MODE AND CONDUCTIVITY CAME INTO RANGE. TREATMENT RESTARTED AT 6:30 PM ON ONE PT. BP 144/64. PT COMPLAINED OF NAUSEA AT 6:50 PM. REGLAN 5 MG GIVEN IV, BP 124/62, BLOOD SUGAR 120, OXYGEN INITIATED AT 2 L/MIN. BP 162/62 AND 170/64 UPON 1/2 HR CHECKS. PT SEEN BY PHYSICIAN AT APPROXIMATELY 8:00 PM. AT 8:10, PT STILL COMPLAINING OF NAUSEA AFTER TREATMENT TERMINATED (8:05) SECOND DOSE OF REGLAN 5 MG IV GIVEN. PT INSTRUCTED THAT NAUSEA WAS LIKELY CAUSED BY DIALYSIS WITH A BATH OF LOW CONDUCTIVITY AND TO AVOID HIGH POTASSIUM FOODS. PT ALSO INSTRUCTED TO CALL PHYSICIAN IF NAUSEA WORSENED OR NEW SYMPTOMS DEVELOPED. UPON RETURNING HOME, PT COMPLAINED OF CHILLS AND NAUSEA. TOOK AN ANTIEMETIC SUPPOSITORY AND WENT TO BED. SEVERAL HRS LATER, PT'S HUSBAND FOUND PT WITHOUT PULSE OR RESPIRATIONS, AND CALLED RESCUE SQUAD. RESCUE SQUAD UNABLE TO REVIVE PT. FOUR OF THE SIX OTHER PTS DIALYZED THE NEXT DAY. 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 MEDICAL CONDITIONS. CORRELATION 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 DELIVER SYSTEM-DIALYSIS FKQ ALTHIN CD MEDICAL, INC. 4009-1

Patients

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