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

Catalog Number FNC1168N

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified number of blood/solution anaesthesia/pca infusion sets had connection cracks which caused leaking at the connection site.This was further described by the customer as when the set was used as an intravenous (iv) line there were no issues, however, when the set was connected to a pca (patient controlled analgesia) device, ¿they were getting blood syphoning up the line/the line was leaking at the pca connection or the pca¿.This was identified during use for patient infusions.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: a batch review was conducted, and there were no deviations found related to this reported condition, during the manufacture of this lot.The actual device was not received for evaluation.Therefore, a device analysis could not be completed.An unspecified quantity of retention samples were visually inspected, and no obvious issues or damages were detected.These samples were also gravity tested.And under water leak tested, with no leaks observed.The retention samples were conforming, as per product specification.The reported condition was not verified, in the retention sample evaluation.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11125541
• MDR Text Key: 225561826
• Report Number: 1416980-2020-08352
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412618388
• UDI-Public: (01)00085412618388
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FNC1168N
• Device Lot Number: 20E16T343
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PCA DEVICE; UNSPECIFIED ANALGESIC DRUG