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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/21/2023

Event Type  Injury  

Event Description

The customer reported that there was a severe hypocalcaemia with citrate related symptoms.The patient was reported as without known allergies, risk factors or pre-existing illness.Per the customer's assessment, this reaction was from acd-a.The collection set is not available for return because it was discarded by the customer.The patient recovered.It is unknown at this time if there was any medical intervention was required for this event.Patient id is unknown at the time.

Manufacturer Narrative

This record is for anticoagulant citrate dextrose solution a(acd-a) 40818 lot 23063024.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, 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 1722028-2023-00259.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.This record is for anticoagulant citrate dextrose solution a(acd-a) 40818 lot 23063024.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that there was a severe hypocalcaemia with citrate related symptoms.The patient was reported as without known allergies, risk factors or pre-existing illness.Per the customer's assessment, this reaction was from acd-a.The collection set is not available for return because it was discarded by the customer.The patient recovered.It is unknown at this time if there was any medical intervention was required for this event.Due to eu personal data protection laws, the patient identifier is not available from 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 (b)(6).See mdr 1722028-2023-00259.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.This record is for anticoagulant citrate dextrose solution a(acd-a) 40818 lot 23063024.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.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the run data file did not indicate a root cause for the reported patient reaction.The system operated as intended and the procedure ran without incident.There were no signals or alarms in the rdf that would indicate issues during the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.The ac infusion rate was set to 1.2ml/min/ltbv.The inlet:ac ratio remained at the default value of 12 as this ratio will properly anticoagulant the system.Both of these values can be adjusted at any time during the run as needed.Furthermore, the optia system offers the ability to perform an additional saline rinse after the tubing set has been primed with saline if hypersensitivity reactions associated with residual ethylene oxide in the tubing set (a result of sterilization) are suspected for the patient.This option is explained in the spectra optia operator¿s manual under ¿selecting procedure options¿.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 that there was a severe hypocalcaemia with citrate related symptoms.The patient was reported as without known allergies, risk factors or pre-existing illness.Per the customer's assessment, this reaction was from acd-a.The collection set is not available for return because it was discarded by the customer.The patient recovered.It is unknown at this time if there was any medical intervention was required for this event.Due to eu personal data protection laws, the patient identifier is not available from the customer.

• 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: 17408445
• MDR Text Key: 320111357
• Report Number: 1722028-2023-00258
• 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: 07/27/2023

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: 4123201
• Device Lot Number: 2304036241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 08/02/2023; 09/28/2023
• Supplement Dates FDA Received: 08/21/2023; 10/09/2023
• 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
• Treatment: ANTICOAGULANT CITRATE DEXTROSE SOLUTION A(ACD-A); ANTICOAGULANT CITRATE DEXTROSE SOLUTION A(ACD-A); ANTICOAGULANT CITRATE DEXTROSE SOLUTION A(ACD-A)
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 71 KG