Catalog Number 03-2622-3 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
|
|
Event Description
|
A hemodialysis (hd) clinic administrator reported to fresenius mexico that the combi set clamps were not occluding and were allowing the passing of blood.It was reported the staff had to use another set of clamps to avoid the issue.Upon follow-up with the clinic, it was reported there was patient blood loss.It was reported that the patient completed their treatment.It was reported the patient lost in-between 100 to 150 ml of blood.It was reported the actual device was discarded but representative samples were available to be returned to the manufacturer for evaluation.Additional information was requested, but was reported to be unavailable.
|
|
Manufacturer Narrative
|
Plant investigation: twenty-one companion samples of the same lot as the product in the reported event were returned to the manufacturer.A physical evaluation was performed.The samples were visually inspected and met specification.A functional test was performed on two companion samples and the alleged event was confirmed when it was observed that fluid from the blood line was returning back to though the saline tubing with the closed clamp in the saline line.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.The event was confirmed.
|
|
Manufacturer Narrative
|
Corrected information: h6- result and conclusion code (incorrectly submitted codes), plant investigation (verbiage corrected to better align with plant investigation) plant investigation: representative samples were returned to the manufacturer for evaluation.All the samples were visually inspected and were found to be within specification.The arterial and venous lines were closely reviewed and no damages was observed.A functional test was performed on two companion samples utilizing the hemodialysis machine 2008t for simulated use and it was observed that fluid from the blood line was returning back through the saline tubing with the closed clamp on the saline line.During the evaluation of the samples, the alleged failure stated in the complaint was confirmed.The device history record (dhr) of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of this lot were found.The product involved was released meeting specifications.
|
|
Manufacturer Narrative
|
Corrected information: b3, g3 (transcription error).
|
|
Search Alerts/Recalls
|