Catalog Number 103579 |
Device Problems
Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6) hospital, pharmacy dept(renal fluids).The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that there was backpressure in a polyflux 170h dialyzer, which led to blood leakage during treatment.A non-baxter dialysis machine was being used at the time of the event.Upon follow up, the customer stated that the lines had not been tightened properly, leading to the leak.The reporter indicated that the patient may have received prophylactic antibiotics.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Baxter renal therapy specialist visited the clinic and reviewed proper procedure with the staff.After reviewing the procedure, the customer indicated that some new staff members had not been tightening the lines properly.The customer has now introduced a second check for the tightness of connections during preparation.The cause of this event could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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