MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LS PRI PLUM 15 MICRON CL 0.2M PE 272CM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140099290

Device Problem Fluid/Blood Leak (1250)

Patient Problem Rash (2033)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The sample is available for evaluation.It is yet to be received.

Event Description

The event occurred on an unknown date.The customer reported a leaking filter of a plum oncology set during chemotherapy infusion.The involved drugs include doxorubicin, gemcitabine, paclitaxel, and cyclophosphamide.There was patient involvement with a reported rash, but no medical intervention was reported.Additionally, there was a delay in critical therapy.

Manufacturer Narrative

Device not available for evaluation.No product samples or videos were returned for investigation.An image was returned for investigation which is a black and white copy and the detail of the complaint cannot be confirmed.The lot history was reviewed and there were no non conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.

• Brand Name: LS PRI PLUM 15 MICRON CL 0.2M PE 272CM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8804676
• MDR Text Key: 151600295
• Report Number: 9615050-2019-00272
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Public: (01)(17)210801(10)929095H
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 140099290
• Device Lot Number: 929095H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYCLOPHOSPHAMIDE, UNK MFR; DOXORUBICIN, UNK MFR; GEMCITABINE, UNK MFR; PACLITAXEL, UNK MFR