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

Catalog Number 10310

Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189)

Patient Problems Tingling (2171); Toxicity (2333); Reaction (2414)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on the spectra optia, additional unplanned calcium gluconate was given via iv to the patient.The patient was symptomatic for citrate toxicity, and experienced tingling and required more calcium than typically required.Per the customer, the patient received 7 grams of calcium gluconate iv over the course of the treatment on (b)(6) 2018.Patient date of birth, outcome and unit id are not available at this time.The lot number is unknown at this time.The cmnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

No adverse event occurred with this event, as it was determined that the iv calcium was a normal prescriptive dose; codes are updated to reflect the investigation as provided in supplement 2 for this mdr.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: based on the signals in the run data files, the spectra optia system operated as intended.The collect pump flow rates remained at 1.0 ml/min for both collections, and based on the inlet pump flow rate and the patient wbc counts, this aligns with the cmnc procedure guidelines for optimizing the collect pump flow rate.There were no indications of any aim system issues that negatively impacted either of these collections.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation: 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.Per customer, the range of calcium that can be administered for any procedure is a part of the standing order (starting off with a lower dose), then increasing the dose, if needed, to alleviate any patient symptoms.Any additional iv calcium reported is still part of the planned prescriptive medication.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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 paresthesia (tingling) but patients may also experience unusual taste, nausea, light headedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Root cause: based on the information provided and the signals in the run data files, the spectra optia system operated as intended.Possible causes of poor collection efficiency include, but are not limited to: aim system issues, clumping in the channel or collect port, and incorrect collect pump flow rates.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

Per the customer, the patient tolerated the procedure 'fine'.The customer declined to provide patient id and age.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7834205
• MDR Text Key: 119339339
• Report Number: 1722028-2018-00230
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2018

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 Expiration Date: 06/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1806283230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 09/06/2018; 10/15/2018; 10/19/2018
• Supplement Dates FDA Received: 09/21/2018; 10/16/2018; 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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 Weight: 71