MAUDE Adverse Event Report: SCHWEINFURT MULTIFILTRATE PRO MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 36-2013-0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hyperthermia (1909); Low Blood Pressure/ Hypotension (1914); Septic Shock (2068)

Event Date 09/18/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, fresenius became aware this patient with renal failure (rf) on continuous venovenus hemodialysis (cvvhd) utilizing a multifiltrate pro in the intensive care unit (icu) experienced a deterioration in condition (hypothermia, hypotension, bacteremia, worsening septic shock, acidosis) due to the multifiltrate pro¿s failure to alarm repetitively.Follow-up documentation revealed on (b)(6) 2023 during the initiation of cvvhd, the dialysis line heater segment was incorrectly attached to an inactive substitute line heater between 15:00 and 17:30.The multifiltrate pro alarmed ¿heater temperature high¿ approximately 5 minutes after the initiation of cvvhd, which was overridden.After silencing the alarm, the multifiltrate pro did not alarm any further.The patient¿s temperature at this time was 35.5 degrees celsius; however, overnight the patient¿s temperature dropped steadily to 30.1 degrees celsius by 11:00.As a result, the multifiltrate pros¿ heater temperature was increased from 38.0 to 39.0 degrees celsius, however it was noted there was no fluid in the heater to warm.A warming blanket was applied to the patient at 38.0 degrees celsius, which kept the patient¿s temperature between 34.0 to 35.0 degrees celsius.At 14:00, the patient¿s warming blanket was discontinued due to the patient¿s agitation.Additionally, the patient¿s dialysate flow rate (dfr) was increased from 2000 ml/hour to 2600 ml/hour, and after an hour of therapy it was again increased to 3000 ml/hour.Following the increase in dialysate flow, the patient¿s temperature began to drop again, and his condition began to deteriorate.The patient¿s lactate level increased from 0.8 mmol/l on (b)(6) 2023 to 7.2 mmol/l on (b)(6) 2023, the patient became acidotic (base excess from -3.3 to -11.1), and the patient¿s noradrenaline requirements increased from 0.05 ml/kg/min to 0.27ml/kg/min.The patient was intubated for increasing agitation and shock at 07:00 on (b)(6) 2023, and his ci-ca anticoagulation was discontinued at 08:00.At approximately 11:00, a consulting physician noted the dialysis line heater segment was incorrectly attached and was reinserted into the proper heater chamber.Following these changes, the patient began to warm (aided by warming blanket), reaching 32.0 degrees celsius by 12.00 and 35.0 degrees celsius by 18.00.Following a review of the alarm history, the cvvhd treatment was stopped in case of machine failure (no blood loss).The clinician caring for the patient stated there is concern regarding the ability to set up the circuit incorrectly without an error message to prompt correction.The incorrectly placed circuit ran for approximately 18 hours with only one alarm near the start of treatment, which contributed to the harm experienced by the patient.As of (b)(6) 2023, the machine was still out of service pending review.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between cvvhd utilizing the multifiltrate pro, and the serious adverse events of hypothermia (characterized by agitation and a decrease in body temperature), hypotension, acidosis, bacteremia, and septic shock, which required admission to the icu, intubation, and increased medication requirements (e.G., vasopressors, normal saline fluid boluses).The root cause of the event was user error when the clinician connected the dialysis line heater segment, to an inactive substitute line heater.However, despite the initial alarm, the multifiltrate pro continued to operate for an additional 18 hours before the connection error was discovered by a physician.Once the connection was corrected, the patient began to stabilize (e.G., decrease in vasopressor requirement, body temperature increased, lab values improved).Based on the totality of the information available, the multifiltrate pro machine cannot be excluded from having a causal or contributory role in this serious adverse event.Given the patient¿s favorable response to the correction of the dialysis line heater segment, the alarm malfunction, and no documentation of the manufacturers¿ evaluation/investigation of the suspect device, the multifiltrate pro cannot be excluded from having a possible causal or contributory role in the serious adverse events.

Event Description

On 19/sep/2023, fresenius became aware this patient with renal failure (rf) on continuous venovenus hemodialysis (cvvhd) utilizing a multifiltrate pro in the intensive care unit (icu) experienced a deterioration in condition (hypothermia, hypotension, bacteremia, worsening septic shock, acidosis) due to the multifiltrate pro¿s failure to alarm repetitively.Follow-up documentation revealed on 18/sep/2023 during the initiation of cvvhd, the dialysis line heater segment was incorrectly attached to an inactive substitute line heater between 15:00 and 17:30.The multifiltrate pro alarmed ¿heater temperature high¿ approximately 5 minutes after the initiation of cvvhd, which was overridden.After silencing the alarm, the multifiltrate pro did not alarm any further.The patient¿s temperature at this time was 35.5 degrees celsius; however, overnight the patient¿s temperature dropped steadily to 30.1 degrees celsius by 11:00.As a result, the multifiltrate pros¿ heater temperature was increased from 38.0 to 39.0 degrees celsius, however it was noted there was no fluid in the heater to warm.A warming blanket was applied to the patient at 38.0 degrees celsius, which kept the patient¿s temperature between 34.0 to 35.0 degrees celsius.At 14:00, the patient¿s warming blanket was discontinued due to the patient¿s agitation.Additionally, the patient¿s dialysate flow rate (dfr) was increased from 2000 ml/hour to 2600 ml/hour, and after an hour of therapy it was again increased to 3000 ml/hour.Following the increase in dialysate flow, the patient¿s temperature began to drop again, and his condition began to deteriorate.The patient¿s lactate level increased from 0.8 mmol/l on (b)(6) 2023 to 7.2 mmol/l on (b)(6) 2023, the patient became acidotic (base excess from -3.3 to -11.1), and the patient¿s noradrenaline requirements increased from 0.05 ml/kg/min to 0.27ml/kg/min.The patient was intubated for increasing agitation and shock at 07:00 on (b)(6) 2023, and his ci-ca anticoagulation was discontinued at 08:00.At approximately 11:00, a consulting physician noted the dialysis line heater segment was incorrectly attached and was reinserted into the proper heater chamber.Following these changes, the patient began to warm (aided by warming blanket), reaching 32.0 degrees celsius by 12.00 and 35.0 degrees celsius by 18.00.Following a review of the alarm history, the cvvhd treatment was stopped in case of machine failure (no blood loss).The clinician caring for the patient stated there is concern regarding the ability to set up the circuit incorrectly without an error message to prompt correction.The incorrectly placed circuit ran for approximately 18 hours with only one alarm near the start of treatment, which contributed to the harm experienced by the patient.As of (b)(6) 2023, the machine was still out of service pending review.

Manufacturer Narrative

Additional information provided in d4.Investigation: the review of the complaints revealed that the reported event is a known event.Machine files reviewed noted that after about 1 minute the warning temperature of heater (green) too high occurs.The over-temperature warning is not related to the fluid inside the heater but is related to the heater-foil on the backside of the heater-tube.The warning occurred because the heater is controlled with a high degree of power to achieve warmed fluid as fast as possible on startup of the treatment.In this case, there is no fluid inside the heater, only air.As the transfer of heat in air is much lower than in water, the heater-control cannot react that fast.The reaction of the machine is correct under these circumstances.In the following course of the treatment, it can be recognized that the heater control keeps the set-point of the temperature quite well.This also continues to happen when the user increases the temperature to 39°c.For this treatment the user did insert the heater bag not into the dialysate heater but in the substitution heater.The machine is not able to recognize this false insertion.During the treatment, the machine controlled the temperature in a correct manner, but only in the heater, which is associated to a cvvhd treatment, i.E.Dialysate heater.Insertion of the cassette is adequately addressed in the instruction for use (ifu).Review of the repair history showed several repair activities.Based on all performed investigations/evaluations the reported event could be reproduced.There is not indication that the product deficiency is related to falsification or an unauthorized configuration.The residual risk is broadly acceptable.

• Brand Name: MULTIFILTRATE PRO MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): SCHWEINFURT; hafenstrasse 9; schweinfurt 97424 ; GM 97424
• Manufacturer (Section G): SCHWEINFURT; hafenstrasse 9; schweinfurt 97424 ; GM 97424
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17904308
• MDR Text Key: 325276409
• Report Number: 0001225714-2023-00078
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 36-2013-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 69 KG