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

Catalog Number 10120

Device Problems Occlusion Within Device (1423); Increase in Pressure (1491); Use of Device Problem (1670); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, they disconnected the patient during the 2nd procedure due to clumping and there is no recirculation observed in the calcium line.The return line was clotted, whereas the inlet line worked fine.On (b)(6) 2018 they started off the procedure with ac ratio of 6:1 and moved up to 8:1 and after processing approximately 200 mls,they observed clumping.They adjusted the ac ratio back down to 4:1 and after processing approximately another 100 mls, it started to clear up.They went up to 5:1 and then 6:1 starting with the ac infusion rate of 1.1.Ml/min/ltbv and lowered it to 1.0 ml/min/ltbv and collected 23 x10^8 cells.Investigation is in process.A follow-up report will be provided.

Event Description

The customer initially contacted terumo bct on (b)(6) 2018, because they observed clumping at the end of the return line connector in the blood warmer tubing during the mononuclear cell collection (mnc) procedure on a pediatric patient with a genetic clotting condition.The customer also received 'return pressure too high ' alarm that resulted in ending the procedure.The customer contacted the terumo bct support specialist for troubleshooting.The customer restarted the procedure with ac ratio of 8:1, further lowering it to 6:1 and processed 400 mls resolving the clumping issue.On 5/10/2018, terumo bct followed up with the customer and found that on (b)(6) 2018, the same pediatric patient with genetic clotting condition experienced a citrate reaction during a mononuclear cell collection (mnc) procedure.At the beginning of the procedure, clumping was noticed and the anticoagulant (ac) infusion rate was adjusted.The patient began experiencing citrate issues and was given oral calcium chews.Approximately 3 hours later, the customer began experiencing access issues and a clot was aspirated from the patient line.In reaction to the citrate reaction and clotting, the patient was given calcium gluconate 13.95 meq =30 ml (diluted to 280 ml ns) through the port and the procedure was ended due to clumping.Per the customer, the patient was reported in stable condition and went home after the procedure.Patient identifier (id) is not available at this time.The mnc 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 and corrected selection.Investigation: the disposable set was not available for return.Per the customer, the lot number was unavailable, therefore, a device history record review could not be conducted.All lots must meet acceptance criteria for release.The run data file was analyzed for the event.Per the run data file, the device operated as intended.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 paraesthesia (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.Root cause: 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 declined to provide the patient identifier.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7561707
• MDR Text Key: 110454652
• Report Number: 1722028-2018-00155
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10120
• Other Device ID Number: 05020583101203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 10/25/2016
• Supplement Dates FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 00011 YR
• Patient Weight: 41