MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO CELLENTIA-H; DIALYZER

Model Number	DD+CT21H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
1 patient / 2 occurrences - where the staff have noticed massive air bubbles in the dialyzer, staff did whatever they could but were not able to clear the bubbles and had to waste the patient's blood.Additional information received 03/02/2021: priming conditions - they prime with a bfr of 100 and flushed the dialyzer with at least a l of saline.Dialysis conditions - bfr 400, dfr - 800, treatment time 4 hrs and no heparin.Brand/manufacturer name & models of devices used together with dialyzer - gambro machine and lines.How much blood did the patient lost due to changing the dialyzer - 300 ml.Was any medical actions taken- none as their hgb (as claimed when they rechecked) was stable.Where did the bubbles generate - middle to top portion of the dialyzer.
Event or Problem Description
1 patient / 2 occurrences - where the staff have noticed massive air bubbles in the dialyzer, staff did whatever they could but were not able to clear the bubbles and had to waste the patient's blood.Additional information received 03/02/2021: 1.Priming conditions - they prime with a bfr of 100 and flushed the dialyzer with at least a l of saline.2.Dialysis conditions - bfr 400, dfr - 800, treatment time 4 hrs and no heparin.3.Brand/manufacturer name & models of devices used together with dialyzer - gambro machine and lines.4.How much blood did the patient lost due to changing the dialyzer - 300 ml.5.Was any medical actions taken- none as their hgb (as claimed when they rechecked) was stable.6.Where did the bubbles generate - middle to top portion of the dialyzer.

• Brand Name: NIPRO CELLENTIA-H
• Common Device Name: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• MDR Report Key: 11558860
• Report Number: 9610987-2021-00001
• Device Sequence Number: 17267449
• Product Code: KDI
• UDI-Device Identifier: 00383790004411
• UDI-Public: 00383790004411
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K160444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/26/2021

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: 06/30/2023
• Device Model Number: DD+CT21H
• Device Catalogue Number: DD+CT21H
• Device Lot Number: 20G27D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/26/2021
• 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