MAUDE Adverse Event Report: TERUMO BCT ACCESSORY PLATELET BAG, ISBT; ACCESSORY PLATELET STORAGE BAG ISBT

Catalog Number 70300

Device Problems Unintended Ejection (1234); Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems Exposure to Body Fluids (1745); No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used platelet storage bag was returned for investigation.Upon visual inspection, it was noted that the bag contained evidence of the platelet product, but no remaining liquid media.The secondary bond socket designated for sterile tubing connections was missing from the assembly.Some residue was found on the exterior of the bond socket that was determined to be dried platelet remnants rather than solvent as it was easily wiped away.No solvent residue was observed on the inner diameter of the secondary bond socket.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported at post collection, a lab technician was transferring platelet products collected from a trima into a platelet accessory bag and noticed that the platelet storage bag was missing a sterile dock tubing line.While transferring the collected product, the technician experienced blood spray in her eyes and mouth.Per the customer, the technician is currently undergoing testing due to the blood exposure and are awaiting test results.Patient identifier and weight are not available at this time.Patient's outcome is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause of the exposure of the technician to blood was a missing line from the secondary bond socket of the accessory bag.The missing line is due to a manufacturing associate error where there was insufficient application of solvent to the tubing.Correction: terumo bct's manufacturing associates were made aware of this issue and retrained to the appropriate procedures.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during follow-up with the customer, the customer stated that during the processing of the unit, the bag was not being compressed and the bag line was not being stripped.The technician had attached the extra platelet accessory bag to the two platelet product bags from the collection procedure.The technician reportedly did not notice the ancillary bag was missing an entire port and open.All 3 bags were hung to equilibrium and the platelet product began to run out of the missing port and onto the bench.The technician took the bags down and laid them on the counter to stop the flow from the port.The bags were laid in the puddle formed and this caused the platelet product to be splashed in the mouth and eyes of the technician.Investigation is in process.A follow-up report will be provided.

Event Description

Donor unit #: (b)(6).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the lab technician was tested due to blood exposure and test results were negative for all viral markers.Investigation is in process.A follow-up report will be provided.

Event Description

The customer declined to provide the patient's weight.

Manufacturer Narrative

This report is being filed to provide additional information.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.

• Brand Name: ACCESSORY PLATELET BAG, ISBT
• Type of Device: ACCESSORY PLATELET STORAGE BAG ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6672007
• MDR Text Key: 78905480
• Report Number: 1722028-2017-00268
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/27/2017

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: 03/01/2019
• Device Catalogue Number: 70300
• Device Lot Number: 03A15296
• Other Device ID Number: 05020583700307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 07/17/2017; 07/24/2017; 08/28/2017; 11/17/2017
• Supplement Dates FDA Received: 07/21/2017; 08/11/2017; 09/05/2017; 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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: 24 YR