MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109990

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Blood Loss (2597)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Lot number: two of the five sets were from lot number 18a1502, and one set was from each of the following lot numbers: 17g2706, 18a3002 and 17k3004.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced blood loss, disseminated intravascular coagulation (dic), and unresponsiveness during continuous renal replacement therapy (crrt) using five prismaflex m150 sets.Approximately 12 hours after the start of therapy, a blood leak detected alarm occurred.However, there was no blood leak noted, only air in the line.The air chamber of the first set was empty and approximately one or two inches of air was noted below the air bubble detector and above the blood leak detector.The reporter stated that the first prismaflex set was discontinued and 56 ml of blood was returned to the patient.The second prismaflex was discontinued after a ¿return extremely positive¿ alarm, and the blood in the circuit was not returned to the patient.The third prismaflex set was discontinued after a warning ¿air in blood¿ alarm which occurred two seconds after start.The treatment was discontinued without blood restitution.The fourth prismaflex set was discontinued after 22 minutes following six ¿access extremely negative¿ and six ¿return extremely positive¿ alarms.The blood returned to the patient was 26 ml.The patient¿s vascular line (catheter) was found to be clotted likely after replacement of the fourth set and the access had to be ¿de clotted¿ prior to restart of crrt.Due to the clot, treatment was not resumed for ¿several hours.¿ the patient was diagnosed with dic and citrate was provided as anticoagulation using the fifth prismaflex set.Around 15-30 minutes after therapy was begun using the fifth prismaflex set, the patient became unresponsive.The accumulated blood loss was approximately 800 ml.No additional information is available.

Manufacturer Narrative

Additional information: a batch review was conducted for all four reported lots, and there were no deviations found related to this reported condition during the manufacture of any of these lots.A photograph of an unspecified sample was received.Visual inspection of the photograph did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified through evaluation of the photograph.An actual sample from lot 18a1502 was received for evaluation.Visual inspection of the returned sample did not identify any abnormalities that could have contributed to the reported condition.No leaks or cracks were detected on the three pod membranes and connections.A priming test was performed with the returned sample, and no leaks or air intake were noted.A self-test was then performed by using the set with a prismaflex machine.The machine did not present any alarms during the self-test.The reported condition was not verified for the returned sample of lot 18a1502.The other involved prismaflex m150 sets were not returned for analysis; therefore, a device evaluation could not be performed for the remaining three sets.The involved prismaflex machine was made available for evaluation.The event history log review revealed that the prismaflex control unit alarmed for air in return line and stopped the treatment.According to the review of the logs, the user did not perform the troubleshooting sequence offered by the machine and instead stopped treatment.The prismaflex device has an air detector that continuously monitors the return line for air bubbles.A warning alarm occurs if a bubble is detected.The return line clamp will close and prevent blood and/or air from passing to the patient.Review of the log files also revealed that the machine had presented access extremely negative, return extremely positive, and clotting alarms.The cause of the alarms presented by the machine could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M150
• 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: 7576222
• MDR Text Key: 110328333
• Report Number: 8010182-2018-00047
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080519
• 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: 06/06/2018,07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 109990
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2018
• Distributor Facility Aware Date: 05/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 61 YR