MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLOW COUPLER; FLOWMETER, BLOOD, CARDIOVASCULAR

Catalog Number 515101300010

Device Problems Fitting Problem (2183); Difficult to Open or Close (2921)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the pins of a 3.0mm flow coupler would not align.It was further reported the pins were offset and the coupler would not close.This issue was identified during patient use.The device was replaced with no further issues.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was performed, and it was noted that two pins on the right ring of the jaw assembly were bent to varying degrees.This condition of the pins would not allow for the flow coupler rings to align as intended; this would lead to the two rings of the jaw assembly to not closing properly.The reported condition was verified.The cause of the reported condition could not be determined.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.

Manufacturer Narrative

Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/07/2021.

• Brand Name: FLOW COUPLER
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11952555
• MDR Text Key: 258668186
• Report Number: 1416980-2021-03431
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): Y
• PMA/PMN Number: K132727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515101300010
• Device Lot Number: SP20L17-1495740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1