MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 191130

Device Problem Device Handling Problem (3265)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between hd therapy utilizing the 2008t hd system and the adverse events of nausea and vomiting.The patient¿s symptoms can be attributed to an improper setup of the 2008t hd system prior to this patient¿s hd treatment as reported by a medical professional.It is well established hd patients may experience adverse events during hd therapy due to multifactorial causes and/or due to the complication of therapy delivery during normal operation.Furthermore, the 2008t hd machine operators¿ manual cautions users of the potential of patient adverse events due to improper hd setup and/or functional checks prior to operation.Therefore, an inherent malfunction or deficiency of the 2008t hd system can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the required information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A hemodialysis registered nurse [(hd)rn] reported to fresenius this hd patient on in-center hd therapy utilizing the 2008t hd system experienced nausea, vomiting and hypotension requiring an emergency department (ed) visit.There was no specific allegation this event was related to an inherent deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s hdrn, it was reported this patient experienced nausea, vomiting and decreased blood pressure approximately 2.5 hours into an hd treatment on (b)(6) 2023.The patient was utilizing the 2008t hd system for the first time since their start on in-center hd therapy in february 2023.The patient became nauseous and pale while their blood pressure dropped slightly, but within normal range.The patient¿s symptoms were minor, so the hd treatment was able to be completed.It was explained the 2008t device was set up improperly prior to the patient¿s treatment that led to low conductivity and the patient¿s subsequent symptoms.The patient was sent to the ed where they received intravenous fluids as they were observed for four hours until they fully recovered.The patient was not admitted to the hospital and released to home on the same day.It was affirmed the patient did not experience a serious injury as a result of the improper set up of the 2008t hd system.Additionally, it was confirmed the patient¿s nausea, vomiting, decreased blood pressure and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s), rather this event was attributed to user error by the dialysis unit.The patient recovered and continues hd therapy on an in-center basis following this event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.

Event Description

A hemodialysis registered nurse [(hd)rn] reported to fresenius this hd patient on in-center hd therapy utilizing the 2008t hd system experienced nausea, vomiting and hypotension requiring an emergency department (ed) visit.There was no specific allegation this event was related to an inherent deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s hdrn, it was reported this patient experienced nausea, vomiting and decreased blood pressure approximately 2.5 hours into an hd treatment on (b)(6) 2023.The patient was utilizing the 2008t hd system for the first time since their start on in-center hd therapy in (b)(6) 2023.The patient became nauseous and pale while their blood pressure dropped slightly, but within normal range.The patient¿s symptoms were minor, so the hd treatment was able to be completed.It was explained the 2008t device was set up improperly prior to the patient¿s treatment that led to low conductivity and the patient¿s subsequent symptoms.The patient was sent to the ed where they received intravenous fluids as they were observed for four hours until they fully recovered.The patient was not admitted to the hospital and released to home on the same day.It was affirmed the patient did not experience a serious injury as a result of the improper set up of the 2008t hd system.Additionally, it was confirmed the patient¿s nausea, vomiting, decreased blood pressure and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s), rather this event was attributed to user error by the dialysis unit.The patient recovered and continues hd therapy on an in-center basis following this event.

• Brand Name: 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18141149
• MDR Text Key: 328181080
• Report Number: 0002937457-2023-01713
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

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: Other
• Device Catalogue Number: 191130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 66 KG