MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M60 SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106696

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 11/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using three prismaflex m60 sets, a pediatric patient experienced thrombocytopenia during a nine-day course.The platelet count on initiation of therapy was 334 (units not reported).The circuit was changed two days after the initiation date with a prismaflex set and then again three days later.The platelet level dropped slowly during the nine-day course to 59 (units not reported) which subsequently led to platelet transfusion (eight days after initiation).Crrt was discontinued nine days after initiation.It was reported citrate was used.No additional information is available.

Manufacturer Narrative

Additional information: the device 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: PRISMAFLEX M60 SET
• 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 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8306762
• MDR Text Key: 135056361
• Report Number: 8010182-2019-00029
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 02/05/2019,03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 106696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Distributor Facility Aware Date: 01/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2019
• Date Manufacturer Received: 02/26/2019
• 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: AQUAPHERESIS UF500; HF1000 FILTER; M100 FILTER; PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Required Intervention
• Patient Weight: 6