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Model Number 914201
Device Problems Crack (1135); Fluid Leak (1250); Failure to Deliver (2338)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 05/28/2020
Event Type  Injury  
Manufacturer Narrative
Device is being investigated by johnson and johnson as the manufacturer of the device. Intera oncology, inc acquired the license and is currently in a transition services agreement with johnson and johnson for its ous market. As this event occured in (b)(6), johnson and johnson is responsible for the investigation and the local reporting of the incident. However, under the transition services agreement, intera oncology is responsible for reporting in the united states. Johnson and johnson is also conducting the investigation into the incident, including possible device return to the manufacturer for evaluation. Technical investigation of the device not yet available; when results are made available, a follow up report will be submitted. (b)(4).
Event Description
Received 05/29/2020: a report from the field indicated that a 40ml medstream programmable infusion pump (product code 914201/serial (b)(4)) used to deliver morphine displayed a hardware 8 failure. The pump was stopped, and medication was substituted. The pump will be explanted. Pump transaction logs are attached to the complaint file. No further information was provided at the time of complaint. As listed in the medstream instructions for use (ifu), pump failure is a known potential event associated with the use of infusion pumps and can result in a return of underlying symptoms, drug withdrawal symptoms, drug overdose, or the need for surgical removal of the pump. Pump hardware failure 8 is high voltage feedback error. The ifu cautions the user to immediately investigate if the pump alarm sounds. The pump reservoir should be emptied immediately if the error message is "pump hardware failure (x)". Customer support should also be contacted. With the information provided, it is not possible to determine the root cause of the hardware failure. It is also unknown if there were any clinical symptoms associated with the hardware failure; therefore, additional information is pending at this time. Since the patient is requiring a corrective invasive procedure in which the pump will be explanted/replaced, the event meets mdr reporting criteria as a "serious injury". However, mdr reporting is now the responsibility of intera oncology, llc. (b)(4): pec: alarm / buzzer (medstream) - hardware failure - 8. Imdrf clinical symptoms code: no information available. Imdrf health impact code: device revision or replacement. Current record type: product complaint. Received 06/18/2020: we received the following additional information for this complaint: what medication was being administered through the pump? morphine. What was the pump implanted to treat? pain. If explanted and being returned due to malfunction, was the pump emptied upon explant? no! are the pump transaction logs available? if yes, please forward them. Yes. Did the physician stop the pump and if so, was the patient put on oral medication? yes. Please provide initial reporter (ie. Physician, clinician, etc) contact information, including name, occupation, e-mail, phone number, fax number, and hospital/facility address: (b)(6). Per fda request, please provide the following patient information, if available: age/dob, gender: m, weight, height, medical history, allergies, race, or ethnicity. Is suspect device(s) available to be returned for analysis. (provide (b)(6) tracking number if/when available). Yes. Also return any products used as a system with the complaint device (i. E, the associated microcatheter, connecting cable, syringe, etc). No! received 06/24/2020: what was the date of the event? (b)(6) 2020. Has the pump been explanted? if so, please provide date of explant. (b)(6) 2020. What does the physician think caused or contributed to the event? hardware fayler 8. Was the patient symptomatic as a result of the event (if so, please list symptoms)? yes, symptoms of drug underdoses. Did the pump system appear damaged in any way (if so, please explain and specify component)? no. What was the date of the patient's last refill? (b)(6) 2020. Was the refill performed as per ifu instructions (if not, please explain)? yes. When was the next planned refill? (b)(6) 2020. What is the current condition of the patient? normal. If you are unable to obtain the patient's age, can you provide a "best guess"? (b)(6) years. Please provide the return status of the device? returned to loc.
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Manufacturer (Section D)
65 william street
suite 200
wellesley MA 02481
Manufacturer (Section G)
65 william street
suite 200
wellesley MA 02481
Manufacturer Contact
sarah lapp
65 william street
suite 200
wellesley, MA 02481
MDR Report Key10192520
MDR Text Key204000192
Report Number3015537318-2020-00001
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number914201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2020 Patient Sequence Number: 1