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

Catalog Number 000000000000070500

Device Problem Air Leak (1008)

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

Event Date 04/23/2014

Event Type  malfunction  

Event Description

The customer reported that at the beginning of a therapeutic plasma exchange (tpe)procedure, they noted some air in the line.The air was entering the line at the connection between the saline line and the connection to the return line diverting toward the patient the customer was able to clear the air from the return line and continue the procedure.No medical intervention was necessary for this event.The patient is in stable condition.The customer declined to provide the patient identifier.The disposable set is not available for return because it was discarded by the customer.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: per the customer, it is their practice to leave the return saline at kvo until instructed by the machine to close it.In the case of this event, the fluid went below the bevel of the needle and some air got into the saline line.They were using a 500ml bag of normal saline.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: in discussion with the customer, a 500ml bag of ns was hooked up to the saline lines.It is estimated that 300ml of saline is used for priming.The return saline clamp was kept at kvo after prime.During the procedure the saline bag emptied and since the clamp was still at kvo, air was able to get into the return saline line.The operator saw this at the time of occurrence and was able to close the clamp before the air returned to the patient.The operator then needed to disconnect the patient to remove the air from the line after connecting a new bag of normal saline.Root cause: air was able to get into the set when the saline bag was not replaced soon enough.The bag emptied and air was drawn into the return line.It is important to ensure that all clamps are closed and the pumps are not moving when replacing the saline bag.To prevent air from entering in the lines, the spectra essentials guide cautions the operator to ensure fluid is flowing into the drip chambers.

Manufacturer Narrative

Investigation: the access pressure is above that of ambient pressure so a pressure head is necessary for air to be returned to the patient.In this situation, it can be stated that there was no pressure head since the air in the line was due to the empty saline bag, therefore, no air could have been returned to the patient.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.A review of the lot for similar reports was carried out and none have been reported.

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.This supplement is being filed to modify information to align with the reported event.

• 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: 3824802
• MDR Text Key: 4500121
• Report Number: 1722028-2014-00188
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831004
• 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: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000000000000070500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Weight: 90