MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX M100 SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 106697

Device Problems Crack (1135); Connection Problem (2900)

Patient Problem Blood Loss (2597)

Event Date 08/23/2016

Event Type  malfunction  

Event Description

Baxter received a voluntary medwatch report (mw5066571) related to prismaflex filter set.The model of the filter set was not identified, neither was the facility the event occurred or contact information provided to follow up with the report.A patient experienced blood loss and delay of treatment when the luer lock of the access or return line broke off inside the catheter.Treatment was stopped and the blood in the circuit was unable to be returned to the patient.The volume of blood loss is unknown as the actual model of the filter set was not reported.It was reported their was no patient harm.

• Brand Name: PRISMAFLEX M100 SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu 69883 ; FR 69883
• Manufacturer (Section G): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu ; FR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2249487578
• MDR Report Key: 6271906
• MDR Text Key: 65569145
• Report Number: 8010182-2017-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106697
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2017
• Distributor Facility Aware Date: 12/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2017
• Date Manufacturer Received: 12/29/2016
• 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: Initial
• Removal/Correction Number: Z-2202-2014
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX
• Patient Outcome(s): Other