[53647]
Us filter corp. 10 technology dr, lowell, ma 01851. On 1/24/96, us filter received a copy of attached medwatch report (access # 1008093) which had been forwarded to us by your office of surveillance and biometrics. Although no deaths or serious injuries occurred as a result of this incident, customer has refused to provide us with necessary info to determine conclusively whether or not malfunction would be likely to cause or contribute to a death or serious injury if malfunction were to recur. Us filter has undertaken an extensive investigation to determine potential causes of problem. Results of our investigation are as follows: community dialysis ctr (vivra renal care) has been a us filter customer since 4/95. We provide them with two, 1. 2 cubic foot mixed bed di resin tanks on an as requested basis. Tanks are used only in event that their primary water system goes down and are installed by dialysis center technicians if necessary. Primary water system equipment as well as other equipment or instrumentation used as part of back-up system were not provided nor are they serviced by us filter. On 11/17/95 customer reuqested us filter to provide new tanks. On 11/18, two 1. 2 cu ft tanks, serial # 27501 and 27569 each containing resin from batch # 8211 were delivered to comm dialysis. On 12/30, us filter received a call from dialysis ctr stating they noticed an odor of chlorine when they went to hook up back-up di tanks. A svc tech was immediately dispatched to location with two new di tanks. Upon arrival at customer site, the svc tech was shown results of chlorine test which had been performed by dialysis tech. Results indicated presence of chlorine. Replacement units were then checked for chlorine, found to be negative and installed by us filter svc tech. Customer refused to let our svc tech take di tanks back with chlorine odor. Subsequent to this incident, us filter has tried to reproduce events which would have had to occur during our processing of tanks to allow a tank to be delivered with chlorine still present. Since the two di tanks in question sat at the customers location for over 6 weeks and since customer refuses to provide us with any of their maintenance logs and or a process and instrumentation diagram of the other equipment on-site, it is possible that the chlorine contamination could have occurred while the dialysis ctr was in possession of the tanks. At this point we are unable to conclusively state the cause of this problem. We also note that the problem has not previously occurred. However, we have reviewed the subject procedures with all personnel involved in this operation to assure compliance with all required steps.
Patient Sequence No: 1, Text Type: D, B5