MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX HF1400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107142

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the effluent line (yellow) was mismatched with the pre blood line (white) line of a prismaflex hf1400 set.This issue was identified when the baxter crrt machine alarmed almost immediately after the patient was connected.Troubleshooting revealed that the effluent and pbp lines had been misassembled in the hf1400 filter set.Treatment was terminated without returning the extracorporeal blood to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: the actual device was not available; however, photographs of the sample were provided for evaluation.The visual inspection of the provided photographs revealed that the pbp and effluent lines were incorrectly assembled on the support plate (pre-pump pbp line inverted with post-pump effluent line).The reported condition was verified.The cause of the condition was determined to be an assembly issue during the manufacturing process.To address this issue, the involved operator has been retrained and awareness training was provided to all operators.The reported lot was manufactured prior to this action.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX HF1400
• 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; ni; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7372402
• MDR Text Key: 103555852
• Report Number: 8010182-2018-00018
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: (01)07332414069315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042938
• 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,Followup
• Report Date: 03/26/2018,04/19/2018

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: 09/01/2019
• Device Catalogue Number: 107142
• Device Lot Number: 17I0704
• 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: 03/26/2018
• Distributor Facility Aware Date: 02/26/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: No
• 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