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

Catalog Number 12320

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

Patient Problems Tingling (2171); Cramp(s) (2193); Reaction (2414)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this lot showed all quality labs and sterilization requirements passed testing and inspection.No irregularities during manufacturing were relevant to the reported adverse event as experienced by the donor/patient.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, 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.Vasovagal reactions such as hypotension and bradycardia as experienced by the patient occur at a frequency of 0.5%.Root cause: a definitive root cause for the donor's reactions could not be determined.This procedure was configured to have an inlet to ac (inlet:ac) ratio of 12 at the start of the run.About 17 minutes into the run, the ratio was increased to 15 and retained for the remainder of the run.Increasing this ratio decreases the amount of anticoagulant brought into the system and subsequently returned to the patient.Furthermore, the maximum ac infusion rate, which determines how quickly ac is delivered back to the patient, was set to 0.90ml/min/ltbv.This infusion rate is within the soft safety limit of 1.2ml/min/ltbv.The device was found to be operating as intended, and within the generally tolerated limits for the majority of patients.There was no system or device malfunction identified that would indicate an issue with the optia system.The optia system appeared to be operating as intended and is safe to use.

Event Description

The customer reported that during a mononuclear cell (mnc) collection procedure on the spectra optia, a healthy donor (after treatment with granocytes) had a very strong citrate reaction with perioral tingling, carp mouth, paw position and slight cramps in the lower legs.After iv calcium administration, there was complete cessation of symptoms.Per the customer, one week after donation they received a message from the donor that they were suffering since the donation with intermittent dizziness, sweats and perioral tingling.According to the family doctor, the patients cardiovascular parameters are stable, and their electrolytes are in the normal range.The spectra optia idl set is not available for return because it was discarded by the customer.

• 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: 7939360
• MDR Text Key: 123042788
• Report Number: 1722028-2018-00274
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2018

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: 01/01/2020
• Device Catalogue Number: 12320
• Device Lot Number: 1801173230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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 Age: 33 YR
• Patient Weight: 79