MAUDE Adverse Event Report: TERUMO BCT RIKA; RIKA PLASMA SEPARATION SET

Model Number 21200

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Dizziness (2194); Pallor (2468)

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer submitted two photographs to aid in the investigation.Both images confirmed that the draw pump door was closed on a small section of the tubing on the outlet side, partially occluding the tubing.First time apheresis donor was given tums as soon as he was seated in the chair.In the first return cycle, many draw centrifuge pressure too high and return centrifuge pressure too high alarms were raised.At this point the donor commented that he was feeling lightheaded.The operator attempted to lay the chair back but was unable to do so.Additional centrifuge pressure too high alarms were raised.The operator checked the loading and venipuncture, and thought everything looked fine so she attempted to continue from the alarm.The centrifuge pressure too high alarms persisted then the operator decreased the return flow rate and continued.Additional centrifuge pressure too high alarms were raised and the operator continued through.The donor began to look pale so the operator initiated rinseback but was unable to complete rinseback due to repeat centrifuge pressure too high alarms.The operator chose end run.After the donor was disconnected and upon close inspection of the set prior to unload terumo associate noticed that the draw pump door was closed on a small section of the tubing on the outlet side, partially occluding the tubing.The customer submitted two photographs to aid in the investigation.Both images confirmed that the draw pump door was closed on a small section of the tubing on the outlet side, partially occluding the tubing.The returned separation set did present an abnormality above the soft cassette which was reported as kinks.However, the separation set was mock loaded onto a device for investigational purposes and this potential tubing kink was naturally stretched.It was concluded that this disposable defect did not contribute to the hemolysis.The contents of the segregated returns were tested for plasma free hemoglobin (pfh).Results revealed negligible hemolysis in the plasma bottle and channel.Elevated pfh in the mesh and donor line confirmed that the hemolyzed blood was being generated while blood was being pushed through the pinched tubing in the draw pump under the misload conditions.Based on system engineering analysis, a bolus of ~0.11 g of pfh was delivered to the donor during the only partial return and saline rinseback.The partial return volume was 23.0 ml, found by the change in bottle volume.The volume returned to the donor during the partial saline rinseback was 30.7 ml, found by the change in accumulated volume of the return pump.The separation set volume from the donor to the draw pump (location of hemolysis generation) is assumed to be 25 ml.Therefore, the volume of plasma returned to the donor containing hemolysis would be 2.9 ml = (return + rinseback ¿ set volumes).This pfh concentration converted to grams = 0.11 g.A review of the certificate of compliance shows that this lot met all acceptance criteria for release.As the reported hemolysis did not relate to activities associated with the manufacture of this lot, further review of the dhr was not performed for this record.A disposable complaint history search was performed for this lot and found another report for similar issues on this lot.Correction: per clinical trial requirements, both the sponsor and investigator physicians were promptly made aware of this event.Additionally, the vitalant technician was retrained to the operator¿s manual alarm prompts as well as loading the separation set which is documented within the clinical trial paperwork.Investigation is in process, a follow-up report will be provided.

Event Description

The customer site reported hemolysis during a plasma donation in the donor line.During the procedure, the device raised many return cps too high alarms starting a the beginning of the first return cycle.After seven alarms, the operator entered rinseback and continued to have return cps too high alarms until they ended the procedure.Hemolysis was not confirmed until the separation set was processed at tbct.There was not a transfusion recipient or patient involved at the time , therefore no patient information is reasonably known at the time of the event and no medical intervention was required for the donor.Donor id:(b)(6).

Manufacturer Narrative

This report is being filed to provide additional information in a.1, a.2, a.3, a.4, b.5, h.6 and h.10.Investigation: the customer submitted two photographs to aid in the investigation.Both images confirmed that the draw pump door was closed on a small section of the tubing on the outlet side, partially occluding the tubing.First time apheresis donor was given tums as soon as he was seated in the chair.In the first return cycle, many draw centrifuge pressure too high and return centrifuge pressure too high alarms were raised.At this point the donor commented that he was feeling lightheaded.The operator attempted to lay the chair back but was unable to do so.Additional centrifuge pressure too high alarms were raised.The operator checked the loading and venipuncture, and thought everything looked fine so she attempted to continue from the alarm.The centrifuge pressure too high alarms persisted then the operator decreased the return flow rate and continued.Additional centrifuge pressure too high alarms were raised and the operator continued through.The donor began to look pale so the operator initiated rinseback but was unable to complete rinseback due to repeat centrifuge pressure too high alarms.The operator chose end run.After the donor was disconnected and upon close inspection of the set prior to unload terumo associate noticed that the draw pump door was closed on a small section of the tubing on the outlet side, partially occluding the tubing.The customer submitted two photographs to aid in the investigation.Both images confirmed that the draw pump door was closed on a small section of the tubing on the outlet side, partially occluding the tubing.The returned separation set did present an abnormality above the soft cassette which was reported as kinks.However, the separation set was mock loaded onto a device for investigational purposes and this potential tubing kink was naturally stretched.It was concluded that this disposable defect did not contribute to the hemolysis.The contents of the segregated returns were tested for plasma free hemoglobin (pfh).Results revealed negligible hemolysis in the plasma bottle and channel.Elevated pfh in the mesh and donor line confirmed that the hemolyzed blood was being generated while blood was being pushed through the pinched tubing in the draw pump under the misload conditions.Based on system engineering analysis, a bolus of ~0.11 g of pfh was delivered to the donor during the only partial return and saline rinseback.The partial return volume was 23.0 ml, found by the change in bottle volume.The volume returned to the donor during the partial saline rinseback was 30.7 ml, found by the change in accumulated volume of the return pump.The separation set volume from the donor to the draw pump (location of hemolysis generation) is assumed to be 25 ml.Therefore, the volume of plasma returned to the donor containing hemolysis would be 2.9 ml = (return + rinseback ¿ set volumes).This pfh concentration converted to grams = 0.11 g.A review of the certificate of compliance shows that this lot met all acceptance criteria for release.As the reported hemolysis did not relate to activities associated with the manufacture of this lot, further review of the dhr was not performed for this record.A disposable complaint history search was performed for this lot and found another report for similar issues on this lot.Correction: per clinical trial requirements, both the sponsor and investigator physicians were promptly made aware of this event.Additionally, the vitalant technician was retrained to the operator¿s manual alarm prompts as well as loading the separation set which is documented within the clinical trial paperwork.Root cause: a root cause assessment was performed for this complaint.The root cause for hemolysis was determined to be an operator misload where the draw pump door was closed on a small section of the tubing on the outlet side, partially occluding the tubing.A root cause assessment was performed for this complaint.The root cause for ac pump not turning at target speed alarm was determined to be an operator misload where the ac pump tubing was not seated in the pump raceway.A root cause assessment was performed for this complaint.The root cause for plasma container not connected during fluid prime alarm was determined to be an operator error where the saline bag membrane was not fully punctured.A root cause assessment was performed for this complaint.Based on the available information a definitive root cause for donor adverse reactions could not be determined but it is likely due to one or a combination of the possible causes listed below: * donor's sensitivity to the procedure * donor's physiology a root cause assessment was performed for this complaint (kinks).The common causes of tubing kinks, indentations, and compressions are typically related to slight variations during set packing and contact of soft tubing with hard components.Following exposure to the heat and humidity of the sterilization cycle, the tubing may assume a deformed shape.

Event Description

The customer site reported hemolysis during a plasma donation in the donor line.During the procedure, the device raised many return cps too high alarms starting a the beginning of the first return cycle.After seven alarms, the operator entered rinseback and continued to have return cps too high alarms until they ended the procedure.Hemolysis was not confirmed until the separation set was processed at tbct.Donor id: 8371345 per the customer, the donor began to look pale so the operator initiated rinseback but was unable to complete rinseback due to repeat centrifuge pressure too high alarms.The operator chose end run.No medical intervention was reported.

• Brand Name: RIKA
• Type of Device: RIKA PLASMA SEPARATION SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 15740037
• MDR Text Key: 307002807
• Report Number: 1722028-2022-00358
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK210635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: 21200
• Device Catalogue Number: 21200
• Device Lot Number: 2207201160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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): Other
• Patient Age: 31 YR
• Patient Sex: Male