MAUDE Adverse Event Report: MILTENYI BIOTEC CLINIMACS; CLINIMACS SYSTEM

Model Number CLINIMACS PLUS INSTRUMENT

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

Patient Problems Abdominal Pain (1685); Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Renal Failure (2041); Tachycardia (2095); Toxicity (2333); Respiratory Failure (2484); Osteopenia/ Osteoporosis (2651)

Event Date 09/19/2014

Event Type  Death  

Event Description

(b)(6) is a (b)(6) boy who was diagnosed as having severe combine immune deficiency on newborn screening.He underwent an unrelated bone marrow transplant on (b)(6) 2014.His course has been complicated by toxicity and infection.He was admitted to the picu on three separate occasions; firstly on (b)(6) 2014 for fluid overload and was transferred back to the bmtu on (b)(6) 2014; secondly on (b)(6) 2014 for severe vod and returned to bmtu on (b)(6) 2014; and lastly on (b)(6) 2014 and stayed until the time of his death.His infectious complications were: disseminated cmv pre and post transplant; disseminated ebv post-transplant; pulmonary aspergillosis; pjp pneumonia (based on clinical symptoms); presumed sepsis culture negative (abdominal pain, tachycardia, hypotension).His toxicities were respiratory failure; severe vod; pulmonary hemorrhage; osteopenia with multiple small bone fractures; pancreatitis; renal insufficiency requiring peritoneal dialysis; ards; hypertriglyceridemia.All medically appropriate intensive care was provided in order to sustain him.However, it had become more difficult to maintain his oxygenation despite the use of oscillator ventilator and nitric oxide.On (b)(6) 2014 he was made and (allowed natural death) by his parents and the picu attending at 0200 and he succumbed at 0955.

• Brand Name: CLINIMACS
• Type of Device: CLINIMACS SYSTEM
• Manufacturer (Section D): MILTENYI BIOTEC; bergisch gladbach; D5142 9
• MDR Report Key: 4119133
• MDR Text Key: 4922852
• Report Number: MW5038339
• Device Sequence Number: 1
• Product Code: KSR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: CLINIMACS PLUS INSTRUMENT
• Device Catalogue Number: 171-01/70025/16201
• Device Lot Number: 6131007010/D0481/B2010
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: SULFAMETHOXAZOLE-TRIMETHOPRIM 45 MG IV Q 6 HOURS; URSODIOL 75 MG BID; CHOLECALCIFEROL 1000 UNITS Q DAY; RITUXIMAB 150 MG IV Q 7 DAYS X 4 DOSES; MEROPENEM 400 MG IV Q 8 HOURS; CHLOROTHIAZIDE 8 MG IV Q 12 HOURS; EPOTIN ALFA 3500 UNITS Q M-W-F IV; GANCICLOVIR 50 MG IV Q 12 HOURS; CLONIDINE 0.2 MG TRANSDERMAL PATCH; VORICONAZOLE 150 MG IV Q 12 HOURS; VANCOMYCIN 150 MG IV Q 18 HOURS; AMPHOTERICIN B LIPOSOMAL 50 MG VI Q DAY; METHYLPREDNISOLONE 5 MG Q 6 HOURS; MICAFUNGIN 50 MG IV Q DAY; IMMUNE GLOBULIN INFUSION IV 3 GRAMS; LORAZEPAM 0.25 MG Q 8 HOURS
• Patient Outcome(s): Death
• Patient Age: 10 MO
• Patient Weight: 11