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 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility inventory manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed in the dialysate compartment.The machine used for treatment was a non-fresenius machine.It was reported that the tablo machine alarmed appropriately in response to the event.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was unable to complete treatment.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

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

Event Description

A user facility inventory manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed in the dialysate compartment.The machine used for treatment was a non-fresenius machine.It was reported that the tablo machine alarmed appropriately in response to the event.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was unable to complete treatment.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d.9, h.3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, an search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Six lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on three of the lots which were unrelated to the complaint event.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 lots met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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 vision systems, and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

Event Description

A user facility inventory manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed in the dialysate compartment.The machine used for treatment was a non-fresenius machine.It was reported that the tablo machine alarmed appropriately in response to the event.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was unable to complete treatment.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: the customer returned a dialyzer from the reported lot for physical evaluation.During the gross visual examination, no defects or irregularities were visually observed on the fiber bundle or any of the molded dialyzer components.The returned sample was subjected to a laboratory bubble point test.An internal leak was detected from a fiber as a steady flow of bubbles were observed to emanate from the cut surface at approximately 185° on the cavity id end with the ports positioned at 0°.The dialyzer was then subjected to destructive disassembly for further visual examination and fiber isolation.Upon extraction of the fiber bundle, a looped fiber was noted from the same area as the leak.Further examination of the fiber bundle did not identify any damage or irregularities.The inferior surface of both polyurethane potting ends were examined; no voids were noted.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 one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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 investigation into the complaint was able to confirm the reported event.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, to assess and improve our products and processes.Capas vision systems, and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

Event Description

A user facility inventory manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed in the dialysate compartment.The machine used for treatment was a non-fresenius machine.It was reported that the tablo machine alarmed appropriately in response to the event.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was unable to complete treatment.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12898404
• MDR Text Key: 285177947
• Report Number: 1713747-2021-00443
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• 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: 21NU01004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Device Age: MO
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 72 KG