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

Catalog Number	10220
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per journal article "therapeutic plasma exchange in hellp syndrome: a life savior".By chowdhry, m., agrawal, s., gajulapalli, s.P., thakur, u.K potential adverse event : three ampoules of injection calcium gluconate 10% diluted in normal saline was administered as a prophylaxis for acid citrate dextrose (acd) induced hypocalcemia.The procedures were well tolerated and there was no serious complication to the patient during or after the procedure.Out of the total nine patients, two patients (22.2%) recovered completely and were discharged on day 15 ± 7 days, whereas 4 (44.4%) patients were discharged on day 21 ± 7 days with the advice of hemodialysis due to persisting kidney injury.Two (22.2%) patients had an intrauterine death and were discharged 3¿4 days after the demise.In all these patients, the tpe was initiated within 24 h of the diagnosis.One patient (11.1%) was referred from a primary health-care center of a two-tier city and could be attended only after a week.Only one plasma exchange could be performed on this patient after the elective lower segment caesarean section (lscs).She later succumbed to acute renal failure and dic.The collection set is not available for return because it was discarded by the customer.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events this report is being filed due to patient death, though at this time there is not an allegation that the device caused or contributed to the patient death.
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Citationl: chowdhry, m., agrawal, s., gajulapalli, s.P., & thakur, u.K.(2022).Therapeutic plasma exchange in hellp syndrome: a life savior.Asian journal of transfusion science, 16(1), 106.Https://doi.Org/10.4103/ajts.Ajts_176_20.
Additional Manufacturer Narrative
Corrected information is provided in h.1.Lot number, manufacture and expiry date are not available at this time.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The two still births were a result of complications developed during pregnancies and not the terumo bct device.No further reporting will be provided as this does not represent a reportable event.Citation: chowdhry, m., agrawal, s., gajulapalli, s.P., & thakur, u.K.(2022).Therapeutic plasma exchange in hellp syndrome: a life savior.Asian journal of transfusion science, 16(1), 106.Https://doi.Org/10.4103/ajts.Ajts_176_20.
Event or Problem Description
Per journal article "therapeutic plasma exchange in hellp syndrome: a life savior".By chowdhry, m., agrawal, s., gajulapalli, s.P., thakur, u.K potential adverse event : three ampoules of injection calcium gluconate 10% diluted in normal saline was administered as a prophylaxis for acid citrate dextrose (acd) induced hypocalcemia.The procedures were well tolerated and there was no serious complication to the patient during or after the procedure.Out of the total nine patients, two patients (22.2%) recovered completely and were discharged on day 15 ± 7 days, whereas 4 (44.4%) patients were discharged on day 21 ± 7 days with the advice of hemodialysis due to persisting kidney injury.Two (22.2%) patients had an intrauterine death and were discharged 3¿4 days after the demise.In all these patients, the tpe was initiated within 24 h of the diagnosis.One patient (11.1%) was referred from a primary health-care center of a two-tier city and could be attended only after a week.Only one plasma exchange could be performed on this patient after the elective lower segment caesarean section (lscs).She later succumbed to acute renal failure and dic.The collection set is not available for return because it was discarded by the customer.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events this report is being filed due to patient death, though at this time there is not an allegation that the device caused or contributed to the patient death.

• Brand Name: SPECTRA OPTIA
• Common Device Name: 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: 20052096
• Report Number: 1722028-2024-00354
• Device Sequence Number: 7896680
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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 Catalogue Number: 10220
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown