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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL UNOMEDICAL INFUSION SET, UNKNOWN MODEL NUMBER

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UNOMEDICAL UNOMEDICAL INFUSION SET, UNKNOWN MODEL NUMBER Back to Search Results
Model Number UNKNOWN
Device Problem No Apparent Adverse Event (3189)
Patient Problems Death (1802); Hypoglycemia (1912); Coma (2417)
Event Date 03/31/2016
Event Type  Death  
Manufacturer Narrative
On 15-ju1-2016: unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 15-aug-2016.
 
Event Description
(b)(4). The sister reported death of her diabetic brother on pump therapy at icu/(b)(6) hospital on (b)(6)2016. Customer was sleeping through the night which was abnormal due to his neuropathy an usual pain. Customer was then unable to be woken up. His blood glucose were 19 mg/dl and the reservoir had no more insulin left when ems arrived and customer was in a coma and was hospitalized on (b)(6) 2016 and then passed on (b)(6) 2016. Diagnosis or official cause of death was hypoglycemia. The sister feels the pump is the cause of death. Has not reported any lot number nor model number of the infusion set used. No further information available.
 
Manufacturer Narrative
On 15-aug-2016: no relevant testing could be performed. If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints. The claimed failure cannot be confirmed. The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents. Unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 15-sep-2016.
 
Event Description
(b)(4). The sister reported death of her diabetic brother on pump therapy at icu/(b)(6) on (b)(6) 2016. Customer was sleeping through the night which was abnormal due to his neuropathy an usual pain. Customer was then unable to be woken up. His blood glucose were 19 mg/dl and the reservoir had no more insulin left when ems arrived and customer was in a coma and was hospitalized on (b)(6) 2016 and then passed on (b)(6) 2016. Diagnosis or official cause of death was hypoglycemia. The sister feels the pump is the cause of death. Has not reported any lot number nor model number of the infusion set used. No further information available.
 
Manufacturer Narrative
On 16-sep-16 clinical evaluation: the spouse of patient reported patient passed away due to hypoglycemia. Patient was found in a coma and was taken to hospital. Patient was hospitalized (b)(6) 2016. Patient passed away (b)(6) 2016. Pump history is not known and there is nothing in the complaint description indicating set malfunction. The spouse of patient reported blood glucose level was down to 19 mg/dl and reservoir was empty indicating overdose of insulin. Chain of event is not clear. More information is necessary to perform a clinical evaluation. On 15-aug-2016: no relevant testing could be performed. If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints. The claimed failure cannot be confirmed. The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.
 
Event Description
(b)(4). The sister reported death of her diabetic brother on pump therapy at icu/(b)(4) on (b)(6) 2016. Customer was sleeping through the night which was abnormal due to his neuropathy an usual pain. Customer was then unable to be woken up. His blood glucose were 19 mg/dl and the reservoir had no more insulin left when ems arrived and customer was in a coma and was hospitalized on (b)(6) 2016 and then passed on (b)(6) 2016. Diagnosis or official cause of death was hypoglycemia. The sister feels the pump is the cause of death. Has not reported any lot number nor model number of the infusion set used. No further information available.
 
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Brand NameUNOMEDICAL INFUSION SET, UNKNOWN MODEL NUMBER
Type of DeviceINFUSION SET
Manufacturer (Section D)
UNOMEDICAL
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
548167000
MDR Report Key5797762
MDR Text Key49627910
Report Number3003442380-2016-00012
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/15/2016 Patient Sequence Number: 1
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