MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA WHITE BLOOD CELL SET

Catalog Number 70600

Device Problem Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Tingling (2171); Cramp(s) (2193); Electrolyte Imbalance (2196); Reaction (2414); Test Result (2695)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the goal of the procedure was to process 24l of blood.The donor was mobilized with g-csf for 4 days prior to the collection per nmdp protocol.On the third day the donor began complaining of severe nausea and received iv zofran in the apheresis unit.She received it again on the fourth day again due to severe nausea.Per the customer, the patient (donor) was given iv calcium gluconate 1g per hour prophylactically during the procedure.Fluids hanging were acda and normal saline.Initial ac infusion rate for the procedure was 1.2ml/min/liter tbv.The physician at the customer site stated that the reaction was caused by citrate.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a donor in the national marrow donor program (nmdp) had a 'severe' citrate reaction during a mononuclear cell (mnc) collection procedure.19 liters into the procedure, the patient complained of tingling, muscle cramping in her jaw, and tetany in her hands.The rn ended the procedure and the medical director was contacted.Per medical director's order, she received an additional 70ml of calcium gluconate diluted in 100ml of 0.9% saline.The donor was admitted to the hospital for evaluation and observation overnight.Perthe rn, the donor's ionized calcium, magnesium and potassium levels were low and she was given additional calcium, magnesium and potassium.The tetany was resolved and she was discharged from hospital the following day in no apparent distress.Per the customer, the donor is healthy and in stable condition.The customer declined to provide patient (donor) identifier, age and weight.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

The disposable set was unavailable for return and further analysis.The manager of qa and apheresis from the customer's site declined the service offer on the machine since the concern of the patient's condition was from the citrate reaction.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, first time procedure patients reactions may occur in approximately 4.8% of procedures, and 1.2% of procedure patients experience reactions to citrate, based on the results of a survey of therapeutic procedures.Of these reactions, most were mild and well tolerated.The cobe spectra system has many safety features.A donor reaction can occur rapidly, however, it is imperative that the operator continuously monitor the cobe spectra system and the donor and/or patient.Root cause: the disposable set was unavailable for specific root cause analysis.The machine service was refused by the customer.Based on information provided by the customer, the donor¿s condition was due to a reaction to acd-a.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury of the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5089541
• MDR Text Key: 26237942
• Report Number: 1722028-2015-00554
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 08/27/2015

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: 02/01/2017
• Device Catalogue Number: 70600
• Device Lot Number: 02Y15274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/05/2015; 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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