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

Catalog Number UNKNOWN- 2008T MACHINE

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

Patient Problems Hypoxia (1918); Itching Sensation (1943); Vomiting (2144); Reaction (2414); Respiratory Failure (2484)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A voluntary medwatch was received which reported that a patient on hemodialysis (hd) for renal replacement therapy (rrt), experienced a suspected allergic reaction to benadryl administered during hd therapy on (b)(6) 2020.The treatment record indicated the patient arrived for their regularly schedule hd treatment.The patient¿s pre-treatment vital signs consisted of a blood pressure (b/p) = 91/45, heart rate (hr) = 80, respirations = 18, 2+ lower extremity edema and bilateral decreased breath sounds.Hd was initiated on a 2008t machine at 17:06 without difficulty and at 17:21 the patient was given intravenous push (ivp) benadryl 25 mg for reported itching.Within minutes of receiving the benadryl, the patient experienced ¿seizure like activity¿ (specifics not provided), changes in mental status and began foaming at the mouth.The treatment was discontinued, and the patient¿s vitals were b/p = 99/42 and a hr = 98.The patient began to vomit (timeline not provided) and was suctioned with good success.Following suctioning, the patient began to clear their throat, at which point emergency medical services (ems) was contacted.The patient was given intravenous (iv) epinephrine 0.3 mg at 17:45, and upon ems¿s arrival the patient¿s eyes were ¿rolling into the back of his head.¿ the patient was non-responsive (despite some grunting) and was transported to the emergency room (er).The discharge summary confirmed the patient presented to the er, obtunded with an altered mental status, significant wheezing/respiratory distress, vomiting, atrial fibrillation (timeline not provided) and hypoxia (oxygen saturation 84% on room air).Vitals upon arrival were a b/p = 114/78, hr = 91 (atrial fibrillation), respirations = 20, temperature = 36.9.Upon arrival to the er, the patient was given an albuterol nebulizer at 17:40, which improved their mentation and oxygenation.Additionally, solumedrol was administered at 17:35, epinephrine (2nd dose) at 17:49, and zofran at 17:46 (resolved vomiting).The patient¿s breathing began to improve, and they received an iv dose benadryl 75 mg (rationale not provided) and became somnolent.The patient received a 3rd dose of epinephrine at 17:55 and continued to improve.In total, the patient received 500 cc of normal saline during the event for a b/p of 120/30.The decision was made to keep the patient overnight for observation, to avert a second allergic reaction when the benadryl and solumedrol wear off.It was reported that the patient has had benadryl many times, and it would be atypical for the patient to have an anaphylactic reaction.The discharge summary indicated causality could be attributed to flash pulmonary edema, secondary to a rapid ventricular response to their atrial fibrillation, based on a chest x-ray.The patient has a documented history of pulmonary edema.The events were also likely to be an allergic reaction to ribs the patient had consumed prior to hd therapy that day.The patient was discharged after approximately 14 hours in stable condition.The patient returned to the outpatient dialysis clinic on (b)(6) 2020 to complete the hd treatment which was discontinued the day before.The patient¿s discharge diagnoses were acute respiratory failure with hypoxia, due to anaphylaxis.

Manufacturer Narrative

Correction: a4, the estimated dry weight was initially reported as 124 kg, however the treatment record indicates the estimated dry weight was 121 kg.Clinical review: a temporal relationship exists between hd therapy utilizing the fresenius 2008t hemodialysis system and the serious adverse events of itching, allergic reaction, vomiting, wheezing, acute respiratory distress and altered mental status, which required emergent discontinuation of hd therapy and medicinal intervention.The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.The discharge summary indicated causality could be attributed to either flash pulmonary edema, secondary to a rapid ventricular response due to atrial fibrillation, as the patient has a documented history of pulmonary edema dating back to (b)(6) 2019.However, given the patient¿s positive response to treatment without the use of diuretics, the events are more likely an allergic reaction to barbeque ribs the patient consumed prior to hd therapy that day.Based on the information available, the fresenius 2008t hemodialysis system can be disassociated from the events.There is no allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction caused or contributed to the serious adverse events.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.Should additional relevant information become available, a supplemental report will be submitted. .

• Brand Name: 2008T 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
• MDR Report Key: 10183776
• MDR Text Key: 196116424
• Report Number: 2937457-2020-01125
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS DIALYZER.; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 121