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

Catalog Number JC7751

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was air in a blood transfusion set; further described by the reporter as an ¿air gap present, and the room is filled completely or not at all¿ (no further detail).This was identified during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information received - the event occurred during patient infusion.Blood was administered using an unspecified pump.There was no patient injury or medical intervention associated with this event.Unspecified pump, therapy date: asku.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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 - DOMINICAN REPUBLIC; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8060673
• MDR Text Key: 126915366
• Report Number: 1416980-2018-07169
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412152738
• UDI-Public: (01)00085412152738
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

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 Expiration Date: 06/30/2023
• Device Catalogue Number: JC7751
• Device Lot Number: DR18F08042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• 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