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

Catalog Number 4123201

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported severe citrate-related hypocalcaemia symptoms such as paresthesia, tetany and dyspnoea during a in stimulated leukapheresis procedure on spectra optia.The patient without known allergies, risk factors or pre-existing illness had this reaction from acd-a.Per follow up with the customer, the patient was given calcium and iv magnesium.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found one additional report for similar issues on this lot, also located at robert-bosch-krankenhaus.See mdr 1722028-2023-00258.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported severe citrate-related hypocalcaemia symptoms such as paresthesia, tetany and dyspnoea during a in stimulated leukapheresis procedure on spectra optia.The patient without known allergies, risk factors or pre-existing illness had this reaction from acd-a.Per follow up with the customer, the patient was given calcium and iv magnesium.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found one additional report for similar issues on this lot, also located at robert-bosch-krankenhaus.See mdr 1722028-2023-00258.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of (b)(4).Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.The run data file (rdf) was analyzed for this event.This procedure indicated the system operated as intended and the procedure was run within standard operating limits.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.A definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.

Event Description

The customer reported severe citrate-related hypocalcaemia symptoms such as paresthesia, tetany and dyspnoea during a in stimulated leukapheresis procedure on spectra optia.The patient without known allergies, risk factors or pre-existing illness had this reaction from acd-a.Per follow up with the customer, the patient was given calcium and iv magnesium.The collection set is not available for return because it was discarded by the customer.Due to eu personal data protection laws, the patient information is not available from the customer.Donor gender and weight were obtained from the run data file (rdf).

• Brand Name: SPECTRA OPTIA
• Type of Device: 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: 17447368
• MDR Text Key: 320285482
• Report Number: 1722028-2023-00259
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4123201
• Device Lot Number: 22063083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2023
• 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): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 72 KG