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

Catalog Number 955052

Device Problems Failure to Infuse (2340); Device Operates Differently Than Expected (2913)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that during a continuous veno-venous hemodiafiltration (cvvh) treatment using a citrate anticoagulation strategy, a patient hypocalcemia occurred, which induced a patient hypotension.The complainant suspected a failure of the calcium syringe pump to explain this patient ionized calcium drop.There was patient involvement.Patient outcome was not reported.Additional information was requested, but is not available at this time.

Manufacturer Narrative

The device was evaluated on-site by a field service technician.An inspection of the device was performed and revealed no issues with the device.The treatment history files were reviewed and revealed that two change syringe procedures had been performed, one on the date of the event and one on the date prior to the event.Further analysis revealed that no calcium was delivered between the change syringe procedures.The reported issue could not be duplicated using the current released software.Ten three hour long simulated treatments with rca anticoagulation and a syringe change within ten minutes of the first self-test have been performed on a control unit with no issues noted.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the condition could not be determined.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - LUND MONITORS; lund skane lan
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7289144
• MDR Text Key: 100694433
• Report Number: 9616026-2018-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CALCIUM LINE PRISMAFLEX CA250; PRISMAFLEX HF1400 SET
• Patient Outcome(s): Other
• Patient Weight: 67