MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008 MACHINE

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

Patient Problems Fall (1848); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Loss of consciousness (2418)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between hd therapy utilizing the unknown hd machine and the adverse event(s) of dizziness, hypotension, loss of consciousness, and fall (hitting head) which warranted hospitalization (>24 hours) on (b)(6) 2021.Given the information provided by the cm (no allegation or deficiency/malfunction), the patient likely experienced an episode of post-treatment orthostatic hypotension due to postural changes.Hypotension is the most prevalent complication associated with hd and occurs in approximately 25% of all treatments.Very often, the cause of the hypotension is multifactorial.Based on the totality of the information available, the unknown hd machine cannot be excluded from having a possible contributory role in the patient¿s hypotension, loss of consciousness and fall (hitting head).There is no allegation (per cm) or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction contributed to the events.If the machine is located/returned, a manufacturer evaluation may dissociate the unknown hd machine from having contributed to the serious adverse events.However, given the temporal relationship, the patient¿s allegations, and the lack of treatment data, this clinical investigation cannot disassociate the device from the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a hemodialysis (hd) patient had passed out due to low blood pressure while trying to walk out on their own and hit their head repeatedly.During follow-up, the patient¿s clinical manager (cm) reported the patient became dizzy due to hypotension following the completion of hd therapy.The patient was hospitalized following the events; however, the admission diagnosis and hospital course are unknown.Additional information was requested (e.G., patient demographics, discharge summary, treatment record), however the information was unavailable due to the patient¿s discharge to another facility.The patient has recovered from the events and is currently undergoing peritoneal dialysis (pd) for rrt.The cm reported there was no allegation being levied against any fresenius device(s) and/or product(s).

Event Description

It was reported that a hemodialysis (hd) patient had passed out due to low blood pressure while trying to walk out on their own and hit their head repeatedly.During follow-up, the patient¿s clinical manager (cm) reported the patient became dizzy due to hypotension following the completion of hd therapy.The patient was hospitalized following the events; however, the admission diagnosis and hospital course are unknown.Additional information was requested (e.G., patient demographics, discharge summary, treatment record), however the information was unavailable due to the patient¿s discharge to another facility.The patient has recovered from the events and is currently undergoing peritoneal dialysis (pd) for rrt.The cm reported there was no allegation being levied against any fresenius device(s) and/or product(s).

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: 2008K MACHINE
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12923349
• MDR Text Key: 281659461
• Report Number: 2937457-2021-02389
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

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: UNKNOWN- 2008 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/13/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/08/2021
• 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): Hospitalization; Required Intervention
• Patient Sex: Female