Catalog Number 0500318E |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/10/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
No patient death, serious injury, and no evidence of reportable product malfunction.
|
|
Event Description
|
A clinic hemodialysis (hd) registered nurse (rn) reported that during hd treatment blood hit the arterial lines to the dialyzer and the machine alarmed of a blood leak.It was also reported that both blood lines had clamped.The machine was pulled and the doctor was notified.Additional follow-up revealed the 2008t hd machine generated a blood leak alarm immediately after the hd therapy was initiated.The patient¿s dialysate flow rate (dfr) was 400 and the patient¿s blood flow rate (bfr) was 200.The rn stated the bloodlines used were fresenius.The leak was noted as being an external blood leak at the arterial side of the dialyzer.No visual damage to the dialyzer or packaging was observed.The patient¿s estimated blood loss (ebl) was less than 100 cc.The rn stated a blood leak test strip was used after the incident to check for the presence of blood in the dialysate and tested positive.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient was able to complete treatment with a new dialyzer on another machine without issue.The rn stated the machine was removed from service and is currently pending testing by the biomed.Per clinic manager the sample was available to be returned for evaluation.
|
|
Manufacturer Narrative
|
The sample was received by the manufacturer for evaluation.During laboratory evaluation, the investigator observed a polyurethane (pu) delamination on the non-cavity id end which extended from approximately 250º to 90º.The delamination in the polyurethane potting extended under the silicone o-ring.No other damage or irregularities were noted on the dialyzer.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint.The lot passed all release criteria.The investigation into the cause of the reported problem was able to confirm the failure mode.There was a confirmed internal leak on the cavity id end of the dialyzer.The complaint has been deemed confirmed.
|
|
Event Description
|
A clinic hemodialysis (hd) registered nurse (rn) reported that during hd treatment blood hit the arterial lines to the dialyzer and the machine alarmed of a blood leak.It was also reported that both blood lines had clamped.The machine was pulled and the doctor was notified.Additional follow-up revealed the 2008t hd machine generated a blood leak alarm immediately after the hd therapy was initiated.The patient¿s dialysate flow rate (dfr) was 400 and the patient¿s blood flow rate (bfr) was 200.The rn stated the bloodlines used were fresenius.The leak was noted as being an external blood leak at the arterial side of the dialyzer.No visual damage to the dialyzer or packaging was observed.The patient¿s estimated blood loss (ebl) was less than 100cc.The rn stated a blood leak test strip was used after the incident to check for the presence of blood in the dialysate and tested positive.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient was able to complete treatment with a new dialyzer on another machine without issue.The rn stated the machine was removed from service and is currently pending testing by the biomed.Per clinic manager the sample was available to be returned for evaluation.
|
|
Manufacturer Narrative
|
Health care professional corrected initial mdr submission statement: removed: no patient death, serious injury, and no evidence of reportable product malfunction," replaced with "a supplemental medwatch report will be submitted upon completion of the investigation.".
|
|
Event Description
|
A clinic hemodialysis (hd) registered nurse (rn) reported that during hd treatment blood hit the arterial lines to the dialyzer and the machine alarmed of a blood leak.It was also reported that both blood lines had clamped.The machine was pulled and the doctor was notified.Additional follow-up revealed the 2008t hd machine generated a blood leak alarm immediately after the hd therapy was initiated.The patient¿s dialysate flow rate (dfr) was 400 and the patient¿s blood flow rate (bfr) was 200.The rn stated the bloodlines used were fresenius.The leak was noted as being an external blood leak at the arterial side of the dialyzer.No visual damage to the dialyzer or packaging was observed.The patient¿s estimated blood loss (ebl) was less than 100cc.The rn stated a blood leak test strip was used after the incident to check for the presence of blood in the dialysate and tested positive.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient was able to complete treatment with a new dialyzer on another machine without issue.The rn stated the machine was removed from service and is currently pending testing by the biomed.Per clinic manager the sample was available to be returned for evaluation.
|
|
Search Alerts/Recalls
|