MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ULTRAFLUX AV 1000 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 01-8981-0

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported to fresenius via a manufacturer incident report (mir) that a patient on continuous renal replacement therapy (crrt) on the multifiltratepro with the ultraflux av 1000s dialyzer experienced abnormal lab values following a suspected clogging of the ultraflux av 1000s dialyzer.The patient's estimated blood loss volume due to the suspected clogging was unknown.Further review of the mir revealed that the local fresenius medical care organization received a report regarding potential clogging events that occurred with an ultraflux av 1000s dialyzer and multifiltratepro crrt machine.During 4 treatments with the multifiltratepro, clogging occurred almost simultaneously in the intensive care unit of (b)(6) hospital.All cases showed an increase in bicarbonate (hco3-) and a clinically relevant reduction in calcium (ca+) substitution simultaneously with an increase in sodium (na+).Crrt treatments were discontinued as the patient¿s hco3- was greater than 40 mmol/l.The treatment sets on the multifiltratepro were exchanged and bicarbonate values decreased (exact value unknown).Treatment settings for this patient were according to protocol, including recommended countermeasures.The exact date of this event was not provided.Additional attempts made by fresenius medical care (schweiz) ag to obtain patient information, further details of the events, treatment data, causality of events and current dispositions of these patients proved unsuccessful.In the reporting, the exact values of ca+ and na+ were not provided and a determination of severity of these lab values cannot be concluded.Though hco3- was elevated to 40 mmol/l, there was no indication the patient developed alkalosis prior to the reduction of hco3- by changing the treatment set.No sample is expected to be returned for evaluation.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: there was no report this patient experienced a serious injury or adverse event as a result of abnormal lab values.Medical intervention for this event included changing the treatment set yet it was affirmed this was done to normalize lab values with no indication this exchange was to reverse any harmful effects of the suspected clogging.Presently there is no objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to any fresenius product(s) or device(s) warranting further investigation.

Manufacturer Narrative

Plant investigation: the complaint sample was not available, and no meaningful pictures were provided impeding further analysis.Due to testing, it is highly unlikely to detect a failure in the retention sample.Furthermore, only a small number of reserve samples are available.Therefore, the retention sample analysis was not performed.A failure during the manufacturing process can be excluded based on the investigation.In the production line, the filters are tested both for their tightness and for open fibers.Additionally, the devices from the reported batch were found to be conforming to specifications per the inspection protocol.The cause for the failure reported cannot be confirmed based on the current available information.

Event Description

It was reported to fresenius via a manufacturer incident report (mir) that a patient on continuous renal replacement therapy (crrt) on the multifiltratepro with the ultraflux av 1000s dialyzer experienced abnormal lab values following a suspected clogging of the ultraflux av 1000s dialyzer.The patient's estimated blood loss volume due to the suspected clogging was unknown.Further review of the mir revealed that the local fresenius medical care organization received a report regarding potential clogging events that occurred with an ultraflux av 1000s dialyzer and multifiltratepro crrt machine.During 4 treatments with the multifiltratepro, clogging occurred almost simultaneously in the intensive care unit of (b)(6) hospital.All cases showed an increase in bicarbonate (hco3-) and a clinically relevant reduction in calcium (ca+) substitution simultaneously with an increase in sodium (na+).Crrt treatments were discontinued as the patient¿s hco3- was greater than 40 mmol/l.The treatment sets on the multifiltratepro were exchanged and bicarbonate values decreased (exact value unknown).Treatment settings for this patient were according to protocol, including recommended countermeasures.The exact date of this event was not provided.Additional attempts made by fresenius medical care (schweiz) ag to obtain patient information, further details of the events, treatment data, causality of events and current dispositions of these patients proved unsuccessful.In the reporting, the exact values of ca+ and na+ were not provided and a determination of severity of these lab values cannot be concluded.Though hco3- was elevated to 40 mmol/l, there was no indication the patient developed alkalosis prior to the reduction of hco3- by changing the treatment set.No sample is expected to be returned for evaluation.

• Brand Name: ULTRAFLUX AV 1000 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14312620
• MDR Text Key: 299762048
• Report Number: 3002807005-2022-00009
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01-8981-0
• Device Lot Number: C2BE3110
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/01/2022
• 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
• Patient Sequence Number: 1
• Treatment: MULTIFILTRATEPRO MACHINE; MULTIFILTRATEPRO MACHINE