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

Catalog Number 000000000000070500

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Date 07/06/2014

Event Type  malfunction  

Event Description

The customer reported that plasma was not collecting in the waste bag during a therapeutic plasma exchange (tpe) procedure.Per the customer, they had given a bag of fresh frozen plasma (ffp) for replacement fluid, but hadn't collected anything in the waste bag.The customer performed rinseback and ended the procedure.A second procedure was set up and started with no issues.Patient information is not available at this time.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for injury has occurred.

Manufacturer Narrative

Investigation: the customer contacted terumo bct support specialist for troubleshooting when they noticed the waste bag was empty.During troubleshoot,the customer stated that the plasma line was 'popping'.They stopped the centrifuge and checked loading to see if plasma came up the plasma line.Little plasma came up the plasma line.The disposable set was returned for investigation.The set was visually inspected for kinks, misassembly, missing parts, occlusions and other defects which may have contributed to the issue, none were found.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the lot for similar reports was carried out, none have been reported.The patient was stable after the second procedure.The medical director recommended an adjustment of tpe volume to account for volume of exchange that was not collecting plasma.The final net apheresis fluid balance was +223ml = 4215 ml volume in - 2992 ml volume out, perthe run sheets.Root cause: the disposable set was analyzed and no anomalies were found.Based on the customer's description of the plasma line pulsing, the plasma was likely not being collected due to an air block.The cause for the air block is inconclusive.It is possible that the kit was still not loaded correctly after resetting.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The patient's full identification number is (b)(6).

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3973648
• MDR Text Key: 4886153
• Report Number: 1722028-2014-00288
• 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,Followup,Followup
• Report Date: 07/06/2014

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: 04/01/2017
• Device Catalogue Number: 000000000000070500
• Device Lot Number: 04W15299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/17/2014; 11/11/2014; 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• 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: 00043 YR
• Patient Weight: 135