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

Catalog Number 90819

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer indicated that the amount of stem cells remaining following the leak was likely insufficient for a satisfactory graft.The patient's time without adequate stem cells will have to be extended as a result of the leak, which increased the risk of infection and the length of the hospital stay, per the customer.One used 2991 round bag and rotating ceramic seal was returned from the customer for investigation.The round bag was leak tested using pressurized air and a leak was noted from a tear/damage approximately 0.5cm in the round bag close to the hanger hole.This tear/damage was confirmed as the source of the leak.The tear was noted to be present on both the top and bottom vinyl layers.The tear/damage was consistent with the round bag being in contact with a sharp object.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during centrifugation of a bone marrow processing procedure,they observed a leak.Per the customer, the patient required an extended unplanned stay at the hospital.Patient outcome is not available at this time.Due to eu personal data protection laws, the patient information is not available from the customer.

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

During follow-up with the customer, the customer indicated that following the transfusion, the patient was doing well.They also stated that due to his age, no further stem cell collection was required.After the transfusion the patient achieved a sufficient level of wbc within 8 days.There was no injury or further issues experienced by the patient.

Manufacturer Narrative

Root cause: the root cause for the cut in the bag could not be conclusively determined from the evaluation of the returned product.The surface of the vinyl is checked for defects during the manufacture of the bag.Possible causes for the cut in the bag include but are not limited to: a sharp edge on one of the spikes or the tubing manifold that caused the cut during shipping and handling.A cut or contact with a sharp edge during customer handling.

Manufacturer Narrative

Additional investigation: per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: COBE 2991
• Type of Device: COBE 2991 BLOOD CELL PROCESSING SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5932922
• MDR Text Key: 54082385
• Report Number: 1722028-2016-00506
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 90819
• Device Lot Number: 10Y15002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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
• Patient Age: 00068 YR