MAUDE Adverse Event Report: CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number 4C8723

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility submitted medwatch (b)(4) for this event.Device manufacturer address: (b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a clearlink system y-type blood/solution set had a ¿pen-sized hole in the line¿ at the connection of the blood filter and iv (intravenous) line which caused a leak of iv fluid.This was further described as ¿once the rn (registered nurse) prepped the lines with the iv solution, liquid began to shoot out of the line¿.This was identified while the nursing staff was getting an icu (intensive care unit) room ready for a patient that was coming out of the operating room post cardiac surgery.Two bags of unspecified iv (intravenous) fluids were hung and connected to the line.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4, h6 and h10.Correction to d4: catalogue # and d4: unique identifier (udi)# d4: catalogue #: the correct catalogue # is 4c8723, previously submitted as 4h8723.D4: unique identifier (udi)#: (01)00085412049076, previously submitted as ni h10: the device evaluation was completed.Visual inspection was performed using the naked eye which observed a hole in the tubing.The other components were correctly placed and according to specifications.Functional clear passage and under water pressure tests were performed and the result of the pressure test was not satisfactory.A leak was observed due to a hole in the tubing.A dimensional test was performed and the product met dimensional specifications.The reported condition was verified.The cause of the condition was due to the expander used in the assembly of the tubing and the filter during the manufacturing process.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• MDR Report Key: 12316524
• MDR Text Key: 266389292
• Report Number: 1416980-2021-04988
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): Y
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

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 Catalogue Number: 4C8723
• Device Lot Number: R21B15058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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