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

Catalog Number 70500

Device Problems Complete Blockage (1094); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that they attempted to perform a plasma exchange procedure through the vortex port.Prior to the start of the procedure, 20cc of yellow clotty material was removed from the vortex port and they had to tpa the line.The customer also stated that the patient has had a history of issues with catheters including the removal of fibrin sheaths.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure, they received multiple alarms including 'return high pressure' and 'access pressure low' alarms.While the operator was troubleshooting, clotting was observed in the return air chamber and at the end of the stop cock of the return tubing line.The operator stopped the procedure without rinse back.The customer stated that the patient was in stable condition when discharged home.The customer followed-up with the patient on the following day and the patient is reported in stable condition.The customer declined to provide patient dentifer.The therapeutic plasma exchange (tpe) set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer stated that they were using an ac ratio of 15:1.The default inlet flow rate was 80ml/min but they had to decrease it to 35 ml/min.There were some access pressure alarms and starting and stopping of the pumps.They had to start a peripheral line and decreased the inlet flow rate down to 20 ml/min.Per the customer, the operators verified there was ac dripping from the anticoagulant drip chamber.Root cause: a definitive root cause for the observed clotting could not be determined.Possible causes include but are not limited to:- inadequate anti-coagulation of the ecv (ac ratio too high); multiple stops during the run due to access issues with the patient's port.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6683093
• MDR Text Key: 79131050
• Report Number: 1722028-2017-00277
• 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: Initial,Followup
• Report Date: 06/30/2017

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 Expiration Date: 01/01/2020
• Device Catalogue Number: 70500
• Device Lot Number: 01A15230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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): Other
• Patient Age: 00048 YR
• Patient Weight: 63