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

Catalog Number 10220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperbilirubinemia (1903); Electrolyte Imbalance (2196); Thrombocytopenia (4431); Insufficient Information (4580)

Event Date 01/01/2014

Event Type  Death  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Abstract citation: arena, r., rabiei, e., srivaths, p., solomon, c., hensch, l., hui, s.-k.R., teruya, j., navaei, a.H.Management of anticoagulation during therapeutic plasma exchange in tandem with extracorporeal membrane oxygenation (ecmo) in critically ill children.Perfusion.2020.35:249 investigation is in process.A follow-up report will be provided.

Event Description

The abstract."management of anticoagulation during therapeutic plasma exchange (tpe) in tandem with extracorporeal membrane oxygenation (ecmo) in critically ill children," discussed a retrospective, single-center case series that evaluated all ecmo patients receiving tandem tpe using spectra optia (terumo bct, lakewood, co, usa) from 2014 to 2017 in a tertiary pediatric hospital.All procedures used plasma for replacement fluid and unfractionated heparin (uh) for anticoagulation.Sixteen patients were included.Median (iqr) age was 3 years (0.7-15), weight 13 kg (7-61), and 69% were male.Indications for tpe included thrombocytopenia associated multi-organ failure 44%, antibody-mediated rejection 12%, hyperbilirubinemia and/or elevated plasma hemoglobin 24%, uncontrollable coagulopathy 12%, severe lupus and catastrophic antiphospholipid syndrome 12%.Mortality and complications: survival to discharge rate was 44%.Hypocalcemia occurred in 24% of procedures; no other complications were reported.The authors concluded tpe can be performed safely in tandem with ecmo and that hypocalcemia occurs due to citrate load from plasma.Individual patient information was not included in the abstract, therefore this report provides a summary of the events and patients.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.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Corrected information is provided in e.1 and e.3.Investigation: since this was a retrospective study between 2014 and 2017, the lot numbers are unknown; therefore, dhr searches could not be conducted for the reported incidents.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

Event Description

Due to the timeframe of this retrospective review, as well guidelines for retrospective chart reviews whereby recorded data must not identify or be linkable to subjects, a request for patient, procedure, and disposable information is not feasible.The author of the abstract confirmed that mortality was related to the underlying condition, not due to therapy or devices.

Manufacturer Narrative

This report is being filed to provide additional information in h10 and h6.Investigation: per the article: "objective: therapeutic plasma exchange (tpe) is used for removal of pathogenic large molecules from plasma and potential survival benefits have been reported in certain clinical conditions among ecmo patients.Due to size and access limitations for pediatric patients, tpe can be performed in tandem with ecmo circuit.There is limited data for anticoagulation management for tandem tpe in children requiring ecmo support.Conclusions: tpe can be performed safely in tandem with ecmo.Hypocalcemia occurs due to citrate load from plasma.Uh can be continued as anticoagulation for tpe during ecmo; however, increased dose is needed to maintain adequate anticoagulation.Sequential monitoring of act and ica is needed during tpe for adequate anticoagulation and detection of hypocalcemia." per internal medical review and analysis, the device did not cause or contribute to these incidents.Root cause: based on the physician's statement, the deaths were related to the patient's pathological medical condition.The occurrences of hypocalcemia were due to the citrate load from the replacement plasma.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET, EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11259189
• MDR Text Key: 229646779
• Report Number: 1722028-2021-00056
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other