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

Model Number 12220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Pain (1994)

Event Date 12/30/2020

Event Type  Death  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the patient complained of pains in the abdomen, knee and joints while red blood cell exchange procedure was going on and calcium gluconate was given.Patient vitals were rechecked, and all necessary attention given.The patient was disconnected and passed away 45 minutes afterwards.Patient id and age are not available at this time.The disposable set is not available for return for evaluation.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer provided photographs of the procedure and end of run summary screens.The photos confirmed the procedure was completed and rinseback was not performed.There were several alarms during the procedure including replacement fluid not detected, return pressure too high and leak detected in the centrifuge.The ac infusion rate was 0.8 ml/min/l tbv.The patient's final fluid balance at the end of the procedure was 100%.Based on the clinical information provided, the spectra optia performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused adverse events.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the patient complained of pains in the abdomen, knee and joints while red blood cell exchange procedure was going on and calcium gluconate was given.Patient vitals were rechecked, and all necessary attention given.The patient was disconnected and passed away 45 minutes afterwards.Patient id and age are not available at this time.The disposable set is not available for return for evaluation.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Event Description

The customer reported that the patient complained of pains in the abdomen, knee and joints while red blood cell exchange procedure was going on and calcium gluconate was given.Patient vitals were rechecked, and all necessary attention given.The patient was disconnected and passed away 45 minutes afterwards.There were no other event or patient details provided.The final customer indicated they were unable to provide any further information.The disposable set is not available for return for evaluation.This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.

Manufacturer Narrative

Investigation: the customer provided photographs of the procedure and end of run summary screens.The photos confirmed the procedure was completed and rinseback was not performed.There were several alarms during the procedure including replacement fluid not detected, return pressure too high and leak detected in the centrifuge.The ac infusion rate was 0.8 ml/min/l tbv.The patient's final fluid balance at the end of the procedure was 100%.Based on the clinical information provided, the spectra optia performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused adverse events.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Based on terumo bct internal medical review conclusion, the spectra optia performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors, nor was there any reported user errors that contributed to or caused adverse events.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for the patient death could not be determined.Possible causes include but are not limited to: * the patient's underlying disease state * an undisclosed medical condition * an unknown event that occurred to the patient that led to death.

• 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: 15781471
• MDR Text Key: 303533939
• Report Number: 1722028-2022-00364
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (y/n): N
• Reporter Country Code: NI
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 01/18/2023
• Supplement Dates FDA Received: 12/27/2022; 01/20/2023
• 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 Sex: Female
• Patient Weight: 46 KG