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.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• 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
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Administrator/Supervisor
• 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

• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 06/23/2020
• 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 Treatment Data

Date Received: 06/23/2020 Patient Sequence Number: 1

Treatment

FRESENIUS DIALYZER