MAUDE Adverse Event Report: TERUMO BCT COBE 2991; COBE 2991 BLOOD CELL PROCESSING SET

Catalog Number 000000000000090819

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Code Available (3191)

Event Date 12/31/2014

Event Type  malfunction  

Event Description

The customer reported three occurences of issues with cobe 2991 disposable sets during a washing procedure.During the connection of the bag to the first set, the spike of the pink tubing detached when the bag was punctured.No leak was observed.During installation of the clamps and connection of defrosting solution to the second set, the blue tubing detached from the manifold.During the start of the centrifuge, the third set began to leak at the blue tubing near the manifold.The customer completed the washing procedure manually.Per the customer, the washing procedure was delayed and caused a delay in the time of the graft.No medical intervention was reported for this event.Due to eu personal data protection laws, the patient information is not available from the customer.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

(b)(6).(b)(4).Sterilization process review investigation: three photographs were submitted of the disposable sets involved.Upon photographic inspection, the first set confirms the detachment of the spike component from the end of the pink striped tubing.The second set shows the blue stripped line detached from the manifold bond socket.No leak is indicated in the picture for the second set.The third picture shows the blue striped tubing circled at the manifold bond socket.No leak is obvious from the picture but the picture does show that all lines leading up to the manifold are sealed.Three sets were sent in for part evaluation from the initial complaint.First set with fluid in it confirmed that the spike detached from the pink stripped tubing.Inspection confirmed that solvent was applied but was insufficient.The 2nd set was dry and confirmed that the blue stripped tubing detached at the manifold junction.Tubing had been inserted to specification but very little solvent was present.The 3rd set had fluid in it and a leak was noted at the blue tubing to manifold junction.The part evaluator gave a slight pull on the tubing and it detached easily.It was confirmed that there was insufficient solvent.The part evaluator also noted that the spike easily detached from the pink tubing also.Two additional unused sets were evaluated from this lot.The first set reviewed did not have any detached tubing initially.However, the part evaluator pulled 9 bonds and found 5 of them detached very easily and insufficient solvent was noted on these bonds.The second unused set showed 6 of 9 bonds detached easily with insufficient solvent noted.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the root cause for these leaks and detached tubings is due to not enough solvent being applied on the tubing during the manufacturing process by the assembler when bonding the tubing into the mating sockets.Correction: manufacturing staff were made aware of this issue and retrained to the appropriate procedures.Corrective action: an internal capa is in process for the disposable solvent application.

Manufacturer Narrative

Investigation: two more additional unused sets from this lot were evaluated.The first set showed 2 of 9 bonds detached easily with insufficient solvent noted.The second set showed 3 of 9 bonds detached easily with patchy solvent noted.Corrective action: no corrective or preventative action is needed for this record at this time.The review indicates that the failure associated with this record did not exceed established statistical limits per our procedure.In addition, terumo bct management reviews trends at least four times per year to consider further appropriate corrective and preventative action.

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 2991
• Type of Device: COBE 2991 BLOOD CELL PROCESSING SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4490972
• MDR Text Key: 5346375
• Report Number: 1722028-2015-00046
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK020041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2015

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: 05/01/2016
• Device Catalogue Number: 000000000000090819
• Device Lot Number: 05W15004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 02/06/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/20/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other