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

Model Number	10310
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow up report will be provided.
Event or Problem Description
For an mononuclear cell collection procedure, the patient's weight was inadvertently entered as 143kg.Patient's actual weight is 63kg.This was noted at approximately 112 minutes into the procedure.System calculated total blood volume (tbv): 6426ml then lowered to 3813ml at 112 minutes.Reported total amount of ac delivered: 1666ml.The customer declined to provide the patient's identifier.The patient is stable.From the patient's record: 1706ml total ac; 43 of ac in collect bag; 1666ml given to patient.Patient did develop tingling, but no other symptoms.Ca+cl 40.8meq iv, 50ml/hour given, per standing order.The disposable set is unavailable for return for evaluation.
Event or Problem Description
For an mononuclear cell collection procedure, the patient's weight was inadvertently entered as 143kg.Patient's actual weight is 63kg.This was noted at approximately 112 minutes into the procedure.System calculated total blood volume (tbv): 6426ml then lowered to 3813ml at 112 minutes.Reported total amount of ac delivered: 1666ml.The customer declined to provide the patient's identifier.The patient is stable.From the patient's record: 1706ml total ac; 43 of ac in collect bag; 1666ml given to patient.Patient did develop tingling, but no other symptoms.Ca+cl 40.8meq iv, 50ml/hour given, per standing order.The disposable set is unavailable for return for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: per the customer there were mid adjustments, the patient weight was lowered down to 63kg at 112 minutes into the procedure.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: per the customer there were mid adjustments, the patient weight was lowered down to 63kg at 112 minutes into the procedure.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for this complaint.The root cause of the possible ac over infusion was determined to be due to an operator error where they entered the incorrect patient weight in the system.Correction: retraining was offered but the customer declined, confirming the issue was addressed by the customer's internal trainer.
Event or Problem Description
For an mononuclear cell collection procedure, the patient's weight was inadvertently entered as 143kg.Patient's actual weight is 63kg.This was noted at approximately 112 minutes into the procedure.System calculated total blood volume (tbv): 6426ml then lowered to 3813ml at 112 minutes.Reported total amount of ac delivered: 1666ml.The customer declined to provide the patient's identifier.The patient is stable and "living".From the patient's record: 1706ml total ac; 43 of ac in collect bag; 1666ml given to patient.Patient did develop tingling, but no other symptoms.Patient¿s procedure was completed successfully with no adverse effects or change in vital signs.Ca+cl 40.8meq iv, 50ml/hour given, per standing order.The disposable set is unavailable for return for evaluation.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA IDL 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: 15566191
• Report Number: 1722028-2022-00330
• Device Sequence Number: 2821705
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: BK150251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 2202011161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 06/06/2023
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 12/16/2022; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACDA 750ML.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 63 KG