MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO CELLENTIA DIALYZER

Model Number	DD+CT21H
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial investigation report attached is on retained samples only.(b)(4).
Event or Problem Description
On (b)(6) 2019, with 1hr and 20 minutes left into a 4.25hr treatment, the system clotted and the staff was unable to return the patient's blood.The clinic set up a new system and patient was able to complete the remaining 1hr and 20 minutes.Patient used to receive heparin but was stopped due to vaginal bleeding.Staff did not record the lot number for the dialyzer used.Clinic checked the patient's hemoglobin levels and they were 9.2g/dl.(dialyzer was disposed) patient has a cvc(dialysis catheter), bfr is 400, dfr is 800.On (b)(6): 2nd incident, same patient, with 1hr and 30 minutes left into a 4.25hr treatment, machine alarmed for high venous pressure, clots were noted on the bloodlines and the dialyzer, but the staff was able to return the patient's blood.Patient received 2000 units of bolus heparin, clinic is giving the patient 100ml of heparin flushes every hour, and will do continuous flushes of 300ml/hr with her next scheduled treatment.Hemoglobin levels were checked and the results were 9 g/dl.Patient is now on max does of aranesp.
Additional Manufacturer Narrative
Initial investigation report attached is on retained samples only.(b)(6)2019: final investigation report on actual used sample is attached.- attachment: [odt report 48359 (190065) 20190801.Pdf, odt report 48359 (190065) 20190909.Pdf].
Event or Problem Description
On (b)(6) 2019, with 1hr and 20 minutes left into a 4.25hr treatment, the system clotted and the staff was unable to return the patient's blood.The clinic set up a new system and patient was able to complete the remaining 1hr and 20 minutes.Patient used to receive heparin but was stopped due to vaginal bleeding.Staff did not record the lot number for the dialyzer used.Clinic checked the patient's hemoglobin levels and they were 9.2g/dl.(dialyzer was disposed) patient has a cvc(dialysis catheter), bfr is 400, dfr is 800 on july 23: 2nd incident, same patient, with 1hr and 30 minutes left into a 4.25hr treatment, machine alarmed for high venous pressure, clots were noted on the bloodlines and the dialyzer, but the staff was able to return the patient's blood.Patient received 2000 units of bolus heparin, clinic is giving the patient 100ml of heparin flushes every hour, and will do continuous flushes of 300ml/hr with her next scheduled treatment.Hemoglobin levels were checked and the results were 9 g/dl.Patient is now on max does of aranesp.

• Brand Name: NIPRO CELLENTIA DIALYZER
• Common Device Name: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 8895285
• Report Number: 9610987-2019-00008
• Device Sequence Number: 1561284
• Product Code: KDI
• UDI-Device Identifier: 00383790004411
• UDI-Public: 00383790004411
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DD+CT21H
• Device Lot Number: 19D01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention