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 Chest Pain (1776); Cramp(s) (2193); Reaction (2414)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Investigation:the customer reported that during the 1st day of the stem cell collection procedures on the donor the collected product clotted.Upon follow-up with the customer, it was confirmed that the first collection product was used and the second collection on the next day was planned.Per the customer, during the 1st day of stem cell collection, they followed their internal protocol and started the collection with the infusion of calcium gluconate intravenously (iv)with maximum allowable infusion rate of 30mg/kg/hr.They found that ionized calcium level of the donor post-procedure was significantly above the reference range.The donor also consumed calcium rich food during the collection procedure.Per the customer, on 2nd day of stem cell collection, the procedure was started with infusion of lower dose of calcium gluconate intravenously at 20mg/kg/hr and with 1gm of tums to betaken orally every 30 minutes to collect a viable non-clotted hematopoietic stem cells (hpc)product.During the 2nd day collection, the ac infusion rate was 1.2ml/min and it was decreased it to 1.0 ml/min.A used optia idl set containing blood was returned to terumo bct for investigation.It was noted that blood had circulated throughout the set.Additionally, blood warmer tubing was returned with the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.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, 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 that a healthy allogeneic donor was undergoing the 2nd day of a stemcell collection procedure on a spectra optia device.Approximately after 2 hours into the stemcell collection procedure, the donor experienced a citrate reaction and complained of chest pains, cramping, numbness and tingling sensation in various parts of his body.Per the rn, the infusion rate of intravenous (iv) calcium gluconate was increased with the continued intake of 1gm of tums orally every 30 minutes.At 1.30pm,the donor complained of reaction symptoms to his face, hands, and calves.The infusion rate of calcium gluconate was increased further to 30mg/kg/hr.At 1.45 pm, the customer reported worsening of donor's symptoms, and as a result the procedure was stopped and tums were given to the donor.The donor was then unable to move his hands and legs,and he had difficulty in opening his eyes and mouth.The donor's vital signs showed tachycardia.As a result, the donor was given a bolus of calcium gluconate with infusion rate of 30 mg/kg/hr, ivf bolus, additional iv bolus and magnesium (mg) were started to the donor intravenously.An electrocardiogram (ekg) was conducted and oxygen(o2) was delivered through nasal cannula (nc).The rn further stated that attending apheresis physician and bmt rn were informed and 911 was called due to prolonged tetany.After the arrival of paramedics, the donor started to feel better and was able to open his eyes and speak easily.Since the muscle tetany was there and continued to be severe in his upper extremities, he was transferred to emergency department accompanied by the rn via ambulance with ivf bolus, calcium gluconate iv and mg iv running to monitor all medications.The magnesium was given as the preventative act.Per the customer, the donor is in emergency room (er) to be treated for the citrate reaction.The customer declined to provide the donor identifier (id) and age.Donor outcome is unknown at this time.

Manufacturer Narrative

This report is being filed to provide additional information in investigation: based on the total ac volume the patient received and the procedure time, theaverage ac infusion rate was calculated as 1.1ml/min/ltbv as reported by the operator.Inabsence of a dlog analysis, the values provided enabled terumo bct to confirm and support thatthere was no device malfunction that led to ac over infusion.Calculated ac infusion rate = (1918/308) x (1/5617) = 1.1 ml/min/ltbvterumo bct provided the customer with the spectra optia concepts of anticoagulant (ac)management inforation.Root cause: a definitive root cause for the donor's reactions could not be determined.Thisprocedure was configured to have an inlet to ac (inlet:ac) ratio of 12 at the start of the run.This was a large volume apheresis procedure.About 2 hours into the procedure, cagluc flow ratewas increased due to increase in symptoms.The maximum ac infusion rate, which determineshow quickly ac is delivered back to the patient, was set to 1.1ml/min/ltbv.This infusion rate iswithin the soft safety limit of 1.2ml/min/ltbv.Possible causes for the donor's citrate reaction include, but are not limited to ac managementduring the procedure, the length of the procedure, and/or the donor's sensitivity toanticoagulant.There was no system or device malfunction identified that would have contributed to the citratereactions as experienced by the donor.

Manufacturer Narrative

This report is being filed to provide additional information in b.5.

Event Description

Per the customer, the donor was stable for the second donation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8600508
• MDR Text Key: 144745271
• Report Number: 1722028-2019-00111
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1902143230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 06/21/2019; 07/03/2019
• Supplement Dates FDA Received: 06/24/2019; 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 80