MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 05/11/2019

Event Type  Injury  

Manufacturer Narrative

Brand name: the reported product is an unknown prismaflex set.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous veno-venous hemodiafiltration (cvvhdf), using an unknown prismaflex set, a disconnection occurred which led to an external blood loss.It was reported the return line disconnected (no further details provided) and the patient experienced a ¿significant amount of blood¿ which required a blood transfusion.The estimated blood loss was not reported.The cause of the disconnection was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: the sample was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8671487
• MDR Text Key: 147090885
• Report Number: 8010182-2019-00138
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2019,07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2019
• Distributor Facility Aware Date: 05/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2019
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Required Intervention