MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BLOOD RECIPIENT SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MMC2071B

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an administration set separated.The event occurred while disconnecting the set from the fluid warmer cartridge, the luer separated from the tubing.Furthermore, the line was connected to a fluid warmer cartridge then connected to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: january 2022.H10: the actual device was not available; however, a photograph of the sample and a retained sample were evaluated.The returned photograph was reviewed, and it was noted that the tubing was detached from the luer connector.The retention sample was visually inspected and did not identify any abnormalities that could have contributed to the reported condition.Functional testing including gravity tested was performed and no leak was observed.The reported condition was verified for the photographic sample.The cause of the 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

H4: device manufacture date: january 2022.H10: the actual device was not available; however, a photograph of the sample and a retained sample were evaluated.The returned photograph was reviewed, and it was noted that the tubing was detached from the luer connector.The retention sample was visually inspected and did not identify any abnormalities that could have contributed to the reported condition.Functional testing including gravity tested was performed and no leak was observed.The reported condition was verified for the photographic sample.The cause of the 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.

• Brand Name: BLOOD RECIPIENT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15064442
• MDR Text Key: 298226105
• Report Number: 1416980-2022-03730
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MMC2071B
• Device Lot Number: 22A23TO54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: FLUID WARMER CARTRIDGE