MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM ROLLER PUMP - 8INCH

Model Number	QRP8
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the photographic evidence, showed dried organic matter (since cleaned, but presumed to be dried blood) running in a horizontal thin line around one of the rollers, we do not have enough evidence to know exactly how long that organic matter had been present, but from the photographs we can see that it was most likely to have been present before the second tube was inserted and would certainly contribute to the very quick degradation of the second tubing set installed.We have found nothing significant with the product to suggest it was faulty equipment.
Event or Problem Description
Tubing rupture on arterial roller during pediatric case.Perfusionist changed out raceway and placed new raceway into roller.After approximately 10 minutes the new tubing could be seen wearing away in the raceway.Roller pump subsequently changed out.Looking at roller pump pictures there appears to be a defect in one of the rollers at the base which is circled in black.
Additional Manufacturer Narrative
No root cause found.
Event or Problem Description
Tubing rupture on arterial roller during pediatric case.Perfusionist changed out raceway and placed new raceway into roller.After approximately 10 minutes the new tubing could be seen wearing away in the raceway.Roller pump subsequently changed out.Looking at roller pump pictures there appears to be a defect in one of the rollers at the base which is circled in black.

• Brand Name: QUANTUM ROLLER PUMP - 8INCH
• Common Device Name: ROLLER PUMP
• Manufacturer (Section D): SPECTRUM MEDICAL LTD.; harrier 4 meteor business park; cheltenham rd east; gloucester, GL29Q L; UK GL29QL
• Manufacturer Contact: colleen powell ; harrier 4 buiness park; cheltenham rd east; gloucester, GL29Q-L ; UK GL29QL
• MDR Report Key: 14336921
• Report Number: 3006073153-2022-00001
• Device Sequence Number: 2366964
• Product Code: DTQ
• UDI-Device Identifier: 05060434420770
• UDI-Public: 05060434420770
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: QRP8
• Device Catalogue Number: 51-000008-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 88 KG