MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number MMC9609L

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number - the customer reported a potentially associated lot number, 18k13t426.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a blood set had clots during priming.The reporter stated that when priming the set for a blood transfusion, large clots were noticed in the chamber of the set.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information :lot number provided: 18k13t426 : the device was received contaminated with blood.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow test was performed and liquid flows through appropriately.The reported problem was not verified.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, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; marsa
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9031413
• MDR Text Key: 159334459
• Report Number: 1416980-2019-05007
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MMC9609L
• Device Lot Number: 18K13T426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1