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

Catalog Number 106696

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.

Event Description

It was reported that a prismaflex m60 set clotted during use, and blood leaked from the pbp tubing.The filter clotted at the pbp line, where it wraps around the blood pump.After the set clotted, the reporter noticed a leak from what appeared to be a tiny pin hole in the tubing.Treatment was stopped and the patient was disconnected.The blood in the circuit was not returned to the patient.The patient had minimal blood loss.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX M60 SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• 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: 7360091
• MDR Text Key: 103423341
• Report Number: 8010182-2018-00017
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064549
• UDI-Public: (01)07332414064549
• 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
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 106696
• Device Lot Number: 17H2803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2018
• Distributor Facility Aware Date: 02/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Date Manufacturer Received: 02/23/2018
• 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