MAUDE Adverse Event Report: TERUMO BCT COBE 2991; BCP 2991

Model Number 90819

Device Problems Use of Device Problem (1670); Expiration Date Error (2528); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that they received blood cell processing set that expired before shipping.The customer proceeded to use some sets before noticing the expiration date.The process that was being performed was a 1-liter wash red blood cells.Nine products in total were processed using the sets.Quality assurance was run on the red cells including an albumin and hematocrit to ensure end products were good to use.Patient id is not available at this time.The patient is stable.The sets were not available for return because they were discarded by 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

The customer reported that they received blood cell processing set that expired before shipping.The customer proceeded to use some sets before noticing the expiration date.The process that was being performed was a 1-liter wash red blood cells.Nine products in total were processed using the sets.Quality assurance was run on the red cells including an albumin and hematocrit to ensure end products were good to use.The patient information of the recipient of the processed blood product is provided in a.2, a.3, a.4.Patient id is not available at this time.The patient is stable.The sets were not available for return because they were discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Inestigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Based on internal documentation, no further action is required.Correction: the customer was aware of the mistake and reported the issue.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that they received blood cell processing set that expired before shipping.The customer proceeded to use some sets before noticing the expiration date.The process that was being performed was a 1-liter wash red blood cells.Nine products in total were processed using the sets.Quality assurance was run on the red cells including an albumin and hematocrit to ensure end products were good to use.The patient information of the recipient of the processed blood product is provided in a.2, a.3, a.4.Patient id is not available at this time.The patient is stable.The sets were not available for return because they were discarded by the customer.

Event Description

The customer reported that they received blood cell processing set that expired before shipping.The customer proceeded to use some sets before noticing the expiration date.The process that was being performed was a 1-liter wash red blood cells.Nine products in total were processed using the sets.Quality assurance was run on the red cells including an albumin and hematocrit to ensure end products were good to use.The patient information of the recipient of the processed blood product is provided in a.2, a.3, a.4.Patient id is not available at this time.The patient is stable.The sets were not available for return because they were discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Based on internal documentation, no further action is required.Correction: the customer was aware of the mistake and reported the issue.Field action 45 was issued to notified of the issue via phone of the expired product shipment.Corrective action: an internal capa has been opened to evaluate the shipment of expired product.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: a request from customer support to use ssl (short shelf life) product led to a delivery from controlled distribution where the product was moved from controlled distribution to create the delivery.For these three requests the product was in restricted stock and the delivery was created without checking the expiry date or realizing the product was in restricted status.Per logistics the product was still in inventory due to low inventory conditions and required an approval to scrap product.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer history report indicates that within the last 90 days from the incident date, no further related issues have been reported for this customer.The expired 2991 sets that were used by the customer were not returned.However, the remaining expired sets that were unused were returned and discarded.Based on the lot number and certificate of compliance, these sets were confirmed to be expired as of 2022/05/01.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Correction: the customer was aware of the mistake and reported the issue.Hence, no additional customer training is required.Corrective action: an internal capa and field action 45 have been opened to reduce the potential for recurrence for this failure.Root cause: a root cause assessment was performed for this complaint.Two root causes were identified and include the following: a failure to verify expiration dates prior to releasing product from a blocked status within the terumo bct inventory system.The operator at the customer site failed to verify that expiry date of the disposable prior to use.

Event Description

The customer reported that they received blood cell processing set that expired before shipping.The customer proceeded to use some sets before noticing the expiration date.The process that was being performed was a 1-liter wash red blood cells.Nine products in total were processed using the sets.Quality assurance was run on the red cells including an albumin and hematocrit to ensure end products were good to use.The patient information of the recipient of the processed blood product is provided in a.2, a.3, a.4.Patient id is not available from the customer.The recipient of the processed rbcs was a patient with a diagnosis of sickle cell anemia, and the patient was stable.No patient was connected to the device during processing.Manufactured date: 2020/05/02.Expiry date: 2022/05/01.The sets were not available for return because they were discarded by the customer.

• Brand Name: COBE 2991
• Type of Device: BCP 2991
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 15195574
• MDR Text Key: 304996591
• Report Number: 1722028-2022-00259
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2022
• Device Model Number: 90819
• Device Catalogue Number: 90819
• Device Lot Number: 05D15001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2020
• 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: 16 YR
• Patient Sex: Male