translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Recall / Field Safety Notice

mdprc 106 03 15 000

2015-03-29

Saudi Arabia

SFDA

https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7368

Baxter healthcare is sending this communication to inform you of errors found in the arabic version of the instructions for use 'homechoice patient at home guide (pahg)' document number 071964016ara-sa, rev.C. the manual was intended to support saudi arabia's need to provide instructions for use on the following homechoice devices which have been distributed in saudi-arabia: - product codes r5c8320, 5c4474 - ce marked and for use with 230 v power supply (product code 5c4474 devices manufactured on or after 26 june 2013, serial numbers 650905 and onwards, were no longer ce marked). - product codes 5c4471, 5c8310 - non-ce marked and for use with 115 v power supply. the following errors were identified: 1) on the second page, it is not specified which product codes are ce marked and which codes are not. 2) on page 235, under electrical power requirements, the power requirements for the 115v configurations have been omitted. the correct supply voltage is mentioned on the labeling on the dataplate of the device, however, that label is in english and might not be understood by a patient using the device. 3) on the page 235 product codes r5c8320 and 5c8310 were incorrectly listed as "r5c8310" and "5c8320". a patient/user may erroneously plug a 115v device into a 230v outlet. this may cause the fuse within the homechoice device to blow rendering the device unusable. this may subsequently result in a slight delay in therapy as patients are able to continue therapy with manual supplies. most patients can also contact their pd centers or technical service for a swap within 24 hour.