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

Catalog Number 10220

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

Patient Problems Dyspnea (1816); Rash (2033); Low Oxygen Saturation (2477)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time investigation: according to the article, "the exchange fluid was a combination of fresh frozen plasma (ffp) and 5% albumin solution with an anticoagulant citrate dextrose, solutiona, (acd-a) anticoagulant solution at 10:1 whole blood:citrate ratio.The flow inlet rate varied between 30 and 70 ml/min according to the type of replacement fluid used and the functioning of the peripheral venous approach.The procedure was performed using the peripheral venous approach with two peripheral catheters 16 gauge diameter each placed at the antecubital veins on both sides for the inlet and the outlet circuits.During tpe, the patient received a prophylactic infusion of calcium supplementation consisting of 10% calcium gluconate to prevent a symptomatic fall in plasma ionized calcium due to citrate anticoagulation.After the first tpe session, respiratory symptoms were significantly improved, the peripheral oxygen saturation increased up to 96%, therefore, subsequent arterial blood gases analyses were between normal ranges." table i.(b)(6) article citation: stoian, a., erban, g., bajko, z., andone, s., mosora, o., balaa, a.Therapeutic plasma exchange as a first choice therapy for axonal guillain barré syndrome: a case based review of the literature (review).Experimental and therapeutic medicine.2021.21 investigation is in process.A follow-up report will be provided.

Event Description

The article, "therapeutic plasma exchange as a first choice therapy for axonal guillain barré syndrome: a case based review of the literature (review)" presents a study in which the authors report the case of a (b)(6) man who had a mild viral respiratory tract infection 1 week prior to the onset of disease with gradual development of a motor deficit, urinary retention, slight swallowing difficulties and mild respiratory dysfunction.Nerve conduction studies were performed and the diagnosis of acute motor axonal neuropathy phenotypic variant of guillain-barré syndrome was established.Autoimmune and inflammatory diseases, infectious diseases, endocrinopathies, neoplastic diseases, intoxications, metabolic diseases and vitamin deficiencies were ruled out.The patient attended four sessions of therapeutic plasma exchange performed using peripheral venous approach with two needles with significant recovery of the motor deficit.Reactions: in the first plasma exchange session (spectra optia), 1.1 plasma volume (pv) was exchanged; in the second session, 1.2 pv was exchanged.In the third session, only 0.5 pv was exchanged because the patient developed an allergic reaction to plasma, with generalized rash, pruritus and dyspnoea with hypo-oxygenation and decreased oxygen saturation of 89%.The procedure was stopped immediately, and 50 mg ranitidine (medochemie ltd.) i.V., 200 mg hydrocortisone hemisuccinate (hhs) (zentiva) i.V.And 10 mg claritin (schering plough labo nv, belgium) orally were administered with rapid allergic reaction regression.On the following day, the fourth exchange was performed with 1.2 pv.Each session was separated by 2 days, except for sessions 3 and 4, which were held on two consecutive days, and a total of 4 pvs were exchanged, and a combination of ffp and 5% albumin solution was used as replacement.Following the initial allergic reaction, the patient received 200 mg hhs (zentiva) i.V.2 h prior to tpe to prevent other allergic reactions.Patient identifier, weight and outcome were not provided in the abstract.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: according to the article, "laboratory testing was performed before the first session of tpe, and then performed after each session to check the complete blood count, calcium, magnesium, potassium, sodium, glucose, creatinine and blood urea nitrogen.There were no significant changes in the above parameters before the first tpe and after the last tpe session.The neurological evaluation performed after plasma exchange session 4, i.E.On day 8 after admission, revealed significant improvement, with regression of motor deficit in all limbs at mrc grade 4/5, and he was able to pass urine, therefore the foley catheter was removed.He experienced no additional tpe related complications during or after the procedure and had no difficulties related to peripheral venous access.We decided to continue kinetotherapy and the supportive treatment with further favorable evolution, and he was discharged 1 week later.The patient was discharged with hfgs grade 2 with an improvement of 2 points compared with that at admission.Ncs performed 2 weeks after admission revealed also significant improvement.One month later, the patient was completely recovered, and the ncs no longer showed pathological changes." according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Investigation is in process.A follow up report will be provided.

Event Description

Pursuant to eu personal data protection laws, the patient identifier and age are not available from the customer.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, e.3, h.6 and h.10.Corrected information is provided in e.1.Root cause: based on information provided in the article, as well as the author's statements, the patient was reacting to the replacement plasma.Allergic reactions are commonly associated with fresh frozen plasma (ffp); some of the possible mechanisms include, but are not limited to: - immediate hypersensitivity reaction (production of ige antibodies in response to allergens (plasma proteins)) - plasma protein deficiency (iga deficiency (iga < 0.05 mg/dl); formation of anti-iga igg antibodies) - haptoglobin deficiency - passive sensitization (passive transfer of donor allergens or donor antibodies (e.G.Allergen-specific ige); transient allergic sensitivity to allergens.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11527934
• MDR Text Key: 256482312
• Report Number: 1722028-2021-00120
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/19/2021

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 03/19/2021; 05/25/2021; 05/26/2021
• Supplement Dates FDA Received: 04/13/2021; 05/26/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention