View source for PNO-III-86-135A, a:on 861118,patient Who Received 2,000 Rads of Radiation Rather than Prescibed 1,200 Rads,Died,Cause Unknown.Nrc & Consultant Will Review Misadministration & Corrective Actions

{{Adams
| number = ML20214F642
| issue date = 11/18/1986
| title = PNO-III-86-135Aa:on 861118,patient Who Received 2,000 Rads of Radiation Rather than Prescibed 1,200 Rads,Died,Cause Unknown.Nrc & Consultant Will Review Misadministration & Corrective Actions
| author name = Axelson W, Wiedeman D
| author affiliation = NRC OFFICE OF INSPECTION &amp; ENFORCEMENT (IE REGION III)
| addressee name = 
| addressee affiliation = 
| docket = 03000394
| license number = 
| contact person = 
| case reference number = FRN-52FR36942, RULE-PR-35
| document report number = AC65-1-078, AC65-1-78, AC65-78, PNO-III-86-135A, NUDOCS 8611250377
| document type = PRELIMINARY NOTIFICATION OF EVENT OR OCCURRENCE (PNO,, TEXT-INSPECTION &amp; AUDIT &amp; I&amp;E CIRCULARS
| page count = 2
}}
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PRELIMINAR NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-III-86-135A Data November 18, 1986 Dl-f S This preliminary notification constitutet EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without v:rification or evaluation, and is basically all that is known by the Region III staff on this date.
Facility: Cleveland Clinic Foundation                                                                                             Licensee Emergency Classification:
9500 Euclid Avenue                                                                                                        Notification of an Unusual Event Cleveland, OH                                                                                                              Alert Site Area Emergency License No. 34-00466-02                                                                                                    General Energency gg                                                                                         X Not Applicable

==Subject:==
THERAPEUTIC MISADMINISTRATION (UPDATE)
R:gion III (thicago) was notified that the 57 year-old female patient who received 2000 rads of radiation rather then the prescribed 1200 rads at the Cleveland Clinic October 6-8, died at 1:04 a.m., November 18, 1986 in the Cleveland P.etropolitan Fospital Burn Clinic.
The patient was admitted to the Burn Clinic on about November 11 with second degree burns l   over 60 percut of her body. She subsequently developed bilateral pneumonia, kidney failure, l   and toxic dermatitis (skin poisoning).                                                                                                                                            q The official cause of her death is unknown at this time. She originally had been treated at the Cleveland Clinic for a blood disease that was considered teminal (Waldstrens macroglobulinanemia).                       (See PNO-III-86-135)
Th3 cobalt-60 teletherapy treatment, according to the consultant, was prescribed as a final effort to effect a remission of her disease.
The prescribed treatment was 400 rads per day (200 in the morning and 200 in the evening) to her upper torso over a three-day period, for a total of 1200 rads.
The NRC medical consultant and Region III radiation inspectors will be at the Cleveland Clinic and Burn Clinic to review the misadministration and the corrective actions. Region III also is requ; sting that patient records, postmortem examinations, and the death certificate be forwarded to the consultant.
t gh DISTRIBUTION:
H. St.                                          EDO                                  NRR                                        E/W         Willste     Mail:  fDM:DMB Chairman Zech                                   PA                                                                              IE          NMSS               COT:Trans only Com. Roberts                                    ELD                                                                            OIA          RES Comm. Asselstine                                                                                                               AE00 Com. Bernthal Comm. Carr                                      SP 3 N                                                                     Pegional Offices         &   . M.       .3.33 ACRS                                                                                                                                                '/
SECY                                            INP0                                                                            NSAC CA                                              RIII Resident Office PDR                                             Licensee:                                                                              (Corp. Office - Reactor Lic. Only) 8611250377 861118 Mg.13I,4G               PNo-Ig.f( -i 3(~                                                                                                           Region III P Dil                                                                                                 Rev. November 1985

PRELJMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCUERENCE--PNO-III-86-135A Date November 18, 1986
                                                     . R gicn III will issue a Confirmatory Action Letter November 18 documenting the licensee's agreement to conduct an interim Quality Assurance / Quality Control program. This program, at a minimum, requires a double verification of prescribed doses, and management audits.
The State of Ohio will be notified. The NRC connissioners' assistants have been briefed.
The patient's relatives and the referring physician have been notified of the cisadministration.
This information is current,as of 1 p.m. (CST), November 18, 1986.
                                                        ]
                                                  /l . / hw CONTACT:    D. G. Wiedeman                 W. L. Axelson FTS 388-5616                   FTS 388-5612 9
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