ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
|
Back to Search Results |
|
Catalog Number 03-2722-9 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/16/2016 |
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 user facility reported that a combi set blood leak occurred approximately two hours after initiation of the patient's hemodialysis (hd) treatment.The complainant stated the venous tubing disconnected from the transducer on the machine resulting in a blood leak.However, no visible issues were identified, the tubing was confirmed as being secure and properly fastened onto the transducer.No machine alarms or system alerts were generated during this event.The majority of the patient's blood within the extracorporeal circuit was returned.The patient's estimated blood loss (ebl) was noted as being approximately 20 cc.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient completed treatment with a new set-up on the same machine.Follow-up information was received which revealed that the bloodline transducers seem to be loose when removed from the packaging.The complaint device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.However, the complainant indicated that companion samples from the same lot were available to be returned to the manufacturing plant for physical analysis.
|
|
Manufacturer Narrative
|
The actual complaint device was not available for physical evaluation, however, thirty-five (35) companion samples from the same lot were returned to the manufacturer for investigation.A visual examination of the returned companion samples found the bloodlines to be acceptable.No defects or irregularities were observed or identified.A single companion sample was then tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a disconnection or a leak from the bloodline companion device.The device worked as intended with no noted abnormalities and no defects identified.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the material and process controls were within specification.The lot passed all release criteria.The investigation into the cause of the reported problem was not able to confirm the failure mode.Although the evaluation of the companion sample confirmed that the device functioned fully as designed and met specification, a definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual complaint device.Therefore, the complaint has been deemed unconfirmed.
|
|
Search Alerts/Recalls
|
|
|