MAUDE Adverse Event Report: NIPRO CORPORATION NIPRO ELISIO-190H HEMODIALYZER; DIALYSIS DIALYZER

Model Number DD+ELISIO-190H

Device Problems Fluid/Blood Leak (1250); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problems Anemia (1706); High Blood Pressure/ Hypertension (1908); Renal Disease, End Stage (2039); Peritonitis (2252); Blood Loss (2597)

Event Date 11/10/2014

Event Type  Injury  

Event Description

Patient had not dialyzed since (b)(6) 2014, on (b)(6) 2014, patient could not dialyze due to clotted avg, physician gave order to wait until monday ((b)(6) 2014) for avg declot and return for regular hemodialysis treatment.On (b)(6) 2014, during 3rd shift, patient came to treatment post avg declot from vascular access center.Patient came to treatment ((b)(6) 2014) with normal tenderness to avg post revision.Patient was cannulated x2 with 15 gauge needles without complications by patient care technician.Because of fluid overload and possible hyperkalemia, the doctor gave verbal order to run for 4hrs.Patient had gained 7.9kg from estimated dry weight; nurse set hemodialysis for 3 hrs with goal at 4.5, and anticipated to sequential ultra filtration only for 1 hr for 2kg.Blood flow rate at 200; dialysate flow rate at 1.5 autoflow; elisio 190-h dialyzer all tests passed; all safety checks passed and verified.After heparin dwell patient treatment initiated and soon after blood leak alarm occurred; confirmed with e-z check blood leak test strip.No blood returned.New system setup with alternate dialzyer and tested.Soon after blood leak alarm occurred and confirmed with e-z check blood leak test strips.No blood returned.Doctor was notified and gave verbal order to setup again with different dialyzer.Pt hemodynamically stable at this time despite blood loss.Machine setup a 3rd time with another dialyzer and tested; soon after initiation of tx blood leak occurred.No blood returned.No other blood leaks occurred this day with any other patient.Doctor notified by facility administrator.Facility administrator and doctor reviewed patient labs and felt that it was best for patient to go to emergency room to be admitted for cvc placement and hemodialysis treatment due to fluid overload, latest potassium (k+) 5.8, and latest hemoglobin (hgb) at 9.9.

Manufacturer Narrative

Investigation currently in process on returned device.

Event Description

Patient had not dialyzed since (b)(6) 2014, on (b)(6) 014, patient could not dialyze due to clotted avg, physician gave order to wait until monday ((b)(6) 2014) for avg declot and return for regular hemodialysis treatment.On (b)(6) 2014, during 3rd shift, patient came to treatment post avg declot from vascular access center.Patient came to treatment((b)(6) 2014) with normal tenderness to avg post revision.Patient was cannulated x2 with 15 gauge needles without complications by patient care technician.Because of fluid overload and possible hyperkalemia, the doctor gave verbal order to run for 4hrs.Patient had gained 7.9kg from estimated dry weight; nurse set hemodialysis for 3 hrs with goal at 4.5, and anticipated to sequential ultra filtration only for 1 hr for 2kg.Blood flow rate at 200; dialysate flow rate at 1.5 autoflow; elisio 190-h dialyzer all tests passed; all safety checks passed and verified.After heparin dwell patient treatment initiated and soon after blood leak alarm occurred; confirmed with e-z check blood leak test strip.No blood returned.New system setup with alternate dialyzer and tested.Soon after blood leak alarm occurred and confirmed with e-z check blood leak test strips.No blood returned.Doctor was notified and gave verbal order to setup again with different dialyzer.Pt hemodynamically stable at this time despite blood loss.Machine setup a 3rd time with another dialyzer and tested; soon after initiation of tx blood leak occurred.No blood returned.No other blood leaks occurred this day with any other patient.Doctor notified by facility administrator.Facility administrator and doctor reviewed patient labs and felt that it was best for patient to go to emergency room to be admitted for cvc placement and hemodialysis treatment due to fluid overload, latest potassium (k+) 5.8, and latest hemoglobin (hgb) at 9.9.

• Brand Name: NIPRO ELISIO-190H HEMODIALYZER
• Type of Device: DIALYSIS DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION; 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita,
• Manufacturer (Section G): NIPRO CORPORATION; 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 4325957
• MDR Text Key: 18796734
• Report Number: 9610987-2014-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2014,04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: DD+ELISIO-190H
• Device Lot Number: 13I16A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2014
• Distributor Facility Aware Date: 11/14/2014
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/17/2014
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Weight: 86