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

Catalog Number 000000000000070700

Device Problem Improper Device Output (2953)

Patient Problems Fainting (1847); Headache (1880); Vaso-Vagal Response (2661)

Event Date 06/15/2015

Event Type  Injury  

Event Description

The customer reported that at the end of a red blood cell exchange (rbcx) procedure, the replacement fluid value was more than expected.The rn noted that approximately one liter more of fluid than expected was in the remove bag and the replacement fluid volume was more than expected.Post procedure, the patient had a vasovagal episode and the patient complained of feeling faint and light-headedness.Per physician's order, iv fluids were given and the patient was admitted overnight stay in the hospital.The patient was discharged the following day without any further follow-up.The patient is reported in stable condition.The customer declined to provide the patient age and identifier.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Additional manufacturer evaluation method (b)(4).The customer stated during the procedure, she noticed that it had taken 40 minutes for the first bag of replacement fluid to be used.She checked the loading of the disposable set and the end hematocrit (hct) and found no issues.Prescribed fluid balance was 100% and the end hct was set to 30%.End hct achieved was 29.7%.Per the customer, a fill-in staff member was running the machine, and may not have run the procedure correctly.A service call was placed and a full machine checkout was performed.The machine is functioning per manufacturer's specification and a saline run was successfully performed.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a definitive root cause for hypovolemia could not be determined.Based on customer comments, possible causes include inaccurate hct entry, or running a depletion procedure instead of exchange.Other possible causes include but are not limited to a misloaded disposable set or disposable issue that is occluding the replacement fluid.

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 in 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 RBCX 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: 4906449
• MDR Text Key: 6535514
• Report Number: 1722028-2015-00252
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

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: 01/01/2018
• Device Catalogue Number: 000000000000070700
• Device Lot Number: 01Y15217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• 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): Hospitalization; Required Intervention
• Patient Weight: 56