MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Model Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry are not available at this time.Customer stated that the acda and 0.9% saline fluids were hung correctly.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that they received the 'cells detected in the plasma line' alarm at the beginning of a therapeutic plasma exchange (tpe) procedure.Hemolysis was noted in the connector and cassette.A cbc and ldh were ordered and the treatment was discontinued.A haptaglobin and that is a send out lab.Test results are unknown at this time but the patient is reported as stable.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: customer stated that the acda and 0.9% saline fluids were hung correctly.Photographs of the interface through the viewport and the cassette were provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.No obvious misassemblies, kinks, or occlusions can be observed in the provided images.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that they received the 'cells detected in the plasma line' alarm at the beginning of a therapeutic plasma exchange (tpe) procedure.Hemolysis was noted in the connector and cassette.A cbc and ldh were ordered and the treatment was discontinued.A haptaglobin and that is a send out lab.Test results are unknown at this time but the patient is reported as stable.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: customer stated that the acda and 0.9% saline fluids were hung correctly.Photographs of the interface through the viewport and the cassette were provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.No obvious misassemblies, kinks, or occlusions can be observed in the provided images.A doctor was unable to confirm that the hemolysis was due to disease state, other treatment or medication.The customer confirmed that the solutions were correctly attached (0.9% normal saline, acd-a and 5% albumin in bottles).Rbcs did not separate when the product/tubing was spun or rested.No clots were observed in the channel or channel lines.The catheter was kinked in two places.The next day, patient hematocrit was 42.2% a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.Root cause: based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: an issue with the patient's catheter.Patient's underlying disease state.Patient's medication and/or medical treatment.Hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to pinched return line resulting in rbc¿s exposed to pressure drop in return line.Hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.The residual total risk is determined to be low.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

Event Description

The customer reported that they received the 'cells detected in the plasma line' alarm at the beginning of a therapeutic plasma exchange (tpe) procedure.Hemolysis was noted in the connector and cassette.The customer stated she did a custom prime.Custom prime hematocrit was 75%.Patient hematocrit 40s%.Treatment was discontinued.A cbc and ldh were ordered and the treatment was discontinued.A haptoglobin and that is a send out lab.Test results are unknown at this time but the patient is reported as stable.The disposable set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 14856339
• MDR Text Key: 303260296
• Report Number: 1722028-2022-00211
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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,Followup
• Report Date: 06/29/2022

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 Model Number: 10220
• Device Catalogue Number: 10220
• Device Lot Number: 2203081161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 11/30/2022; 01/17/2023
• Supplement Dates FDA Received: 12/12/2022; 01/25/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 16 KG