MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500316E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility reported that an internal dialyzer blood leak occurred five minutes after initiation of a patient¿s hemodialysis treatment.It was reported that the blood was observed in the dialysis compartment and outside the membranes of the arterial head.The machine, a fresenius 4008s, alarmed appropriately with a blood leak alert.Blood leak test strips were not used.No further damage and/or defects were noted.It was unknown if fresenius bloodlines were being utilized for the treatment or if the patient¿s blood was returned.The estimated blood loss (ebl) was reportedly 20 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on the same machine after re-setting up supplies.The dialyzer was reported to be discarded and no longer available for manufacturer evaluation.A photo was provided for the investigation.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.Three photographs were provided for the investigation.Each photo shows a different angle of a used dialyzer.There is blood visible outside of the fiber bundle in the dialysate fluid indicative of an internal leak.The source of the leak is not visible in any of the photographs.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The complaint is confirmed.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas 2018-0171 (vision systems) and 2018-0161 (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

Event Description

A user facility reported that an internal dialyzer blood leak occurred five minutes after initiation of a patient¿s hemodialysis treatment.It was reported that the blood was observed in the dialysis compartment and outside the membranes of the arterial head.The machine, a fresenius 4008s, alarmed appropriately with a blood leak alert.Blood leak test strips were not used.No further damage and/or defects were noted.It was unknown if fresenius bloodlines were being utilized for the treatment or if the patient¿s blood was returned.The estimated blood loss (ebl) was reportedly 20 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on the same machine after re-setting up supplies.The dialyzer was reported to be discarded and no longer available for manufacturer evaluation.A photo was provided for the investigation.

Manufacturer Narrative

Plant investigation: the complaint device was not returned for manufacturer evaluation.The reported complaint was confirmed with three photographs provided for the investigation.Each photo shows a different angle of a used dialyzer.There is blood visible outside of the fiber bundle in the dialysate fluid indicative of an internal leak.The source of the leak is not visible in any of the photographs.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The complaint is confirmed.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas 2018-0171 (vision systems) and 2018-0161 (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

Event Description

A user facility reported that an internal dialyzer blood leak occurred five minutes after initiation of a patient¿s hemodialysis treatment.It was reported that the blood was observed in the dialysis compartment and outside the membranes of the arterial head.The machine, a fresenius 4008s, alarmed appropriately with a blood leak alert.Blood leak test strips were not used.No further damage and/or defects were noted.It was unknown if fresenius bloodlines were being utilized for the treatment or if the patient¿s blood was returned.The estimated blood loss (ebl) was reportedly 20 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on the same machine after re-setting up supplies.The dialyzer was reported to be discarded and no longer available for manufacturer evaluation.A photo was provided for the investigation.

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14915350
• MDR Text Key: 303305383
• Report Number: 0001713747-2022-00234
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 22AU06019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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: FRESENIUS 4008S MACHINE; FRESENIUS 4008S MACHINE; FRESENIUS 4008S MACHINE
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 36 KG