HEPARIN FLUSH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for HEPARIN FLUSH manufactured by Bd.

Event Text Entries

[107021846] The pt is a (b)(6) with severe hemophilia a with an implantable port for administration of recombinant clotting factor. He developed bacteremia with serratia marcescens and had to undergo port removal. Typically, his port is infused with clotting factor several times a week, and the port is flushed with heparin prior to de-access. We received notification from bd regarding a heparin flush recall that included lot numbers which had been given to our pt. The recall was due to concern regarding serratia marcescens contamination. The pt has severe hemophilia a with an inhibitor. He was receiving regular factor infusions (immune tolerance induction, daily factor infusions plus daily infusions of factor for prophylaxis). He developed a hematoma over his port in (b)(6), which eventually resolved. He continued to have problems with his port throughout the winter. The area was frequently inflamed and swollen. It was thought that he either had an unresolved hematoma or had developed an infection. As his port is critical for his medication administration, we worked to keep his port in. While awaiting the port area to heal (when we're presuming it was a hematoma), he did not receive factor infusions and developed a joint bleed which required hospital admission in (b)(6) 2018. He then developed a blister like lesion over his port in (b)(6) 2018 which prompted the port removal. The removal of the post resulted in losing iv access for this pt and a switch to a different product to treat his hemophilia - hemlibra. The admission for his port removal was 3 days. The pt was treated with oral antibiotics after initial iva antibiotics. If he would not have had an infection in his port, he would have remained on his factor and not switched medications (to a new medicine that was newly fda approved but my plan was to wait for a few months of add'l data before switching products). Further, if he would not have had a port infection, i would have kept the port in for easy iv access for at least 2 more years.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5076827
MDR Report Key7471919
Date Received2018-04-27
Date of Report2018-04-25
Date of Event2018-03-13
Date Added to Maude2018-04-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHEPARIN FLUSH
Generic NameHEPARIN FLUSH
Product CodeNZW
Date Received2018-04-27
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBD


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-04-27

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