MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET PARADIGM; QUICK-SET PCC

Model Number MMT-397

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 06/30/2017

Event Type  Death  

Manufacturer Narrative

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

Unomedical reference number (b)(4).In (b)(6) 2017 a male diabetic patient died of a heart attack.The wife called because she had come across a recall letter and that the infusions sets he had were part of the recall.The customers wife was looking to reach out, she was concerned that the infusion set was a reason why he died.Customer was wearing pump at time of passing.The wife reported although, that the husband suffered from a heart disease and he just had three new stents put in.He was doing well, but then went into cardiac arrest.No further information provided.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: QUICK-SET PCC
• Manufacturer (Section D): UNOMEDICAL A/S; 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 Key: 7124922
• MDR Text Key: 95159948
• Report Number: 3003442380-2017-00030
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-397
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Death